FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM MANUAL PROGRAM 7321.006 

TRANSMITTAL NUMBER: 2023-CPM-CFSAN-004 Date of issuance: 9/28/2023 Page 1 of 71

CHAPTER 21 - FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS

SUBJECT: INFANT FORMULA PROGRAM – INSPECTION, SAMPLE

COLLECTION AND EXAMINATION

IMPLEMENTATION DATE: Upon Receipt

PRODUCT CODES: See Table 1

PRODUCT/ASSIGNMENT 

CODES (PAC)

21006 Infant Formula Survey 

21006N Domestic Infant Formula Environmental Samples

NOTE: The work to be accomplished under this compliance program has been identified as high 

priority by CFSAN. The firms to be inspected and the products to be collected are considered high 

risk because of the susceptible population for which the products are intended. ORA Office of 

Human and Animal Food Operations (OHAFO) and Office of Import Operations (OIO) are 

required to complete 100% of the operations planned in the ORA Field Workplan for this program.
FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM MANUAL PROGRAM 7321.006 

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Table 1. Product Code Description

Industry Code: 40

Product Description Code

Milk base formula product, powder formula) 40P[][]01 

Milk base formula product, liquid concentrate) 40O[][]01 

Milk base formula product, ready to feed) 40N[][]01 

Soy base formula product, powder formula) 40P[][]02 

Soy base formula product, liquid concentrate) 40O[][]02 

Soy base formula product, ready to feed) 40N[][]02 

Whey base formula product, powder formula) 40P[][]03 

Whey base formula product, liquid concentrate) 40O[][]03 

Whey base formula product, ready to feed) 40N[][]03 

Other formula products, N.E.C., powder formula) 40P[][]99 

Other formula products, N.E.C., liquid concentrate) 40O[][]99 

Other formula products, N.E.C., ready to feed) 40N[][]99 

Milk base human milk fortifier) 40S[][]01 

Human milk base human milk fortifier) 40S[][]02 

Goat milk base formula product, powder formula) 40P[][]05 

Goat milk base formula product, liquid concentrate) 40O[][]05 

Goat milk-base formula product, ready to feed) 40N[][]05 
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FIELD REPORTING REQUIREMENTS:

1. Inspection

Report all inspections into eNSpect. Scan product labeling, promotional literature and brochures 

into eNSpect as an exhibit. Hard copy establishment inspection reports (EIRs) are not required. 

2. Sample Collections and Import Field Examinations 

Report all domestic sample collections in the Field Accomplishment Compliance Tracking System 

(FACTS). 

Report all import sample collections and field/label examinations in the appropriate import system. 

Report sample collections and/or examinations utilizing the following Problem Area Flags (PAF):

PAF PAF Description Product Type

LBL Labeling Finished infant formula 

MIC Microbiological Analysis Finished infant formula for 

microbiological analysis 

NIS Nutrition Sample 

Reporting

Finished infant formula for nutrients 

analysis

3. Analytical

a) Per FMD-147, ORA laboratories will communicate sample analytical findings to the 

appropriate compliance units and other FDA stakeholders identified in the compliance 

program. Preliminary and final results will be communicated using the CRO/Final Result

SharePoint Notification tool

b) All final results will be entered into the Field Accomplishment and Compliance Tracking 

System (FACTS) and completed analytical worksheet packets will be uploaded to 

Compliance Management System (CMS) as soon as possible following final result 

notification. 

c) Per FMD-147 and the ORA Laboratory Manual, completed original analytical findings will 

be submitted electronically to the responsible party named in the Collection Remarks on 

the Collection Report in an FDA 1551 Form. 
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Contents

PART I – BACKGROUND ..........................................................................................................6

PART II - IMPLEMENTATION................................................................................................13

PART III – INSPECTIONAL .....................................................................................................17

A. Inspections ............................................................................................................................17

B. Import Operations .................................................................................................................37

C. Sample Collection (During Domestic Inspection) ................................................................40

D. Sample Size ...........................................................................................................................42

E. Sample Shipment ..................................................................................................................43

PART IV – ANALYTICAL .......................................................................................................46

PART V - REGULATORY/ADMINISTRATIVE STRATEGY ...............................................53

1. Situations Presenting a Health Hazard ..................................................................................53

2. Domestic and Foreign Inspections ........................................................................................54

3. Imported Infant Formula .......................................................................................................56

4. Charges .................................................................................................................................57

5. Requirements Related to Recalls ..........................................................................................58

PART VI REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS ....................59

A. Reporting Changes in Processing and Reformulation for Infant Formulas ..........................60

B. Infant Formula Nutrient Information Reporting Form .........................................................60

C. Foreign Infant Formula Manufacturers and Products ...........................................................60

D. Domestic Infant Formula Manufacturers and Products ........................................................60
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PART VII - CENTER RESPONSIBILITIES .............................................................................63

ATTACHMENT A .....................................................................................................................64

Reporting Changes in Processing and Formulation for Infant Formulas ...................................64

ATTACHMENT B .....................................................................................................................67

Infant Formula Nutrient Information Reporting Form ...............................................................67

ATTACHMENT C .....................................................................................................................70

Infant Formula Products Manufactured by Foreign Manufacturers ...........................................70

ATTACHMENT D .....................................................................................................................71

Infant Formula Products Manufactured by Domestic Manufacturers ........................................71
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PART I – BACKGROUND

This compliance program provides instructions and tools for FDA investigators, laboratory analysts, 

and compliance officers. It is a comprehensive approach to covering inspection, sample collection, 

sample analysis, and compliance activities to accomplish FDA’s mission to ensure infant formula 

products in the U.S. food supply are safe and wholesome. 

The term “infant formula” is defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 

section 201(z) and in Title 21 section 106.3 of the Code of Federal Regulations (CFR) as “a food 

which purports to be or is represented for special dietary use solely as a food for infants by reason of 

its simulation of human milk or its suitability as a complete or partial substitute for human milk.” The 

term “infant” is defined as “a person not more than 12 months of age.” (21 CFR 106.3). Furthermore, 

if a formula is labeled for an age where some of that range includes less than 12 months (e.g., 9 to 18 

months), then the product is regulated as an infant formula. 

The FD&C Act also provides special requirements for infant formula for infants with special medical 

and dietary needs. “Exempt infant formula” is a term used for any infant formula that is represented 

and labeled for use by an infant who has an inborn error of metabolism or low birth weight, or who 

otherwise has an unusual medical or dietary problem (see section 412(h)(1) of the FD&C Act). 

Exempt infant formulas are exempt, under section 412(h) of the FD&C Act, from certain aspects of 

the infant formula requirements. The following link provides a list of exempt infant formula 

manufacturers and products currently available in the U.S. marketplace: 

http://www.fda.gov/Food/Guidance 

Regulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm106456.htm. 

 

There are three forms of infant formula: 

• powder (must be reconstituted with water before feeding); 

• ready-to-feed/ready-to-use liquid (do not add water before feed); 

• concentrated liquid (must be mixed with water before feeding). 

Typically, powder infant formula is manufactured by one of three manufacturing schemes: (1) wet 

mix/spray dry/powder fill, (2) wet mix/spray dry/dry blend/powder fill, or (3) dry blend/powder fill. 

Liquid infant formulas typically undergo processing to make them commercially sterile, but powder 

infant formula is not sterile. Therefore, powder infant formula requires additional safety 

considerations and microbiological testing. The microbiological pathogens identified for testing of 

powdered infant formula are Cronobacter species (spp.) and Salmonella spp. 

A. Pathogens 

1. Salmonella 

Salmonella is the one of the main causes of foodborne illnesses in the United States. 

Incidence of salmonellosis in infants (i.e., a person not more than 12 months of age) is ~8 

times higher than other age groups. In addition to infants, people with a weakened immune 
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system such as the elderly are more likely to have severe salmonellosis infections. Some 

Salmonella spp. can survive drying particularly well and are difficult to kill with heat when 

the Salmonella cells are dehydrated or are in low moisture products such as milk powder and 

powder infant formula. Symptoms of salmonellosis generally develop 12-72 hours following 

infection and usually lasts four to seven days and most people recover without treatment. 

Most people with salmonellosis develop diarrhea, fever, and abdominal cramps, and in some 

rare instances, bacteremia and/or meningitis in infants. More severe cases of salmonellosis 

may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in 

some cases may be fatal. 

2. Cronobacter 

Cronobacter spp. are gram-negative rod-shaped opportunistic pathogens within the family 

Enterobacteriaceae. They are naturally found in the environment although the specific 

reservoir is unknown. They are particularly good at surviving in dry environments and dry 

food such as milk powder, powder infant formula, starches, and herbal teas. The genus 

Cronobacter consists of seven species: C. sakazakii, C. condimenti, C. dublinensis, C. 

malonaticus, C. muytjensii, C. turicensis, and C. universalis. Although several of those 

species are capable of causing illness in humans, C. sakazakii is the most common species

associated with illness. Cronobacter is harmless for most people. Typically, Cronobacter 

illnesses occur in infants younger than two months or those with underlying conditions, such 

as those who are premature, immunocompromised, and/or of low birthweight, although term 

infants without underlying conditions have experienced invasive Cronobacter spp. infections 

as well. Infections in infants can be deadly, with case-fatality rates ranging from 10% to 80%. 

3. Environmental Pathogens 

Salmonella spp. and Cronobacter spp. are pathogenic bacteria that are particularly welladapted to survival through prolonged periods of dry/dehydration and other environmental 

conditions and are difficult to control. These organisms can survive drying particularly well 

and are difficult to kill with heat when they are dehydrated or in low moisture products. Both 

Salmonella and Cronobacter may enter a food facility several ways that can include, but are 

not limited to: 

• Incoming raw ingredients 

• Pallets (or skids) 

• Personnel and traffic movement 

• Equipment design and construction 

• Pest vectors 

• Facility integrity (roof leaks, etc.) 

• Airflow, including dusts and/or aerosols 

The growth of these organisms is favored in those areas of a manufacturing plant where water 

occasionally wets the area, either intentionally as part of periodic wet cleaning, or 

inadvertently as the result of leaking pipes or valves or a leaking roof. An ideal growth and 

survival environment is one which periodically gets wet (even if only once every few months) 

and then takes at least one day or more to fully dry. For example, when equipment is mounted 
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on the floor of the plant, water may seep under the structure of the equipment and then remain 

wet for many days. This type of area is considered to be a niche environment that enables the 

accumulation of residues (food debris, dust, and water). When environmental pathogens 

become established in a niche environment(s) it may be difficult to locate and eliminate them. 

These organisms may spread to other areas of the food processing plant from this niche 

environment(s) by various means such as dust, worker’s feet, moving equipment such as 

forklifts and totes, strong air currents, and water used during wash down procedures, etc. 

Niche environments may be difficult to inspect or access and therefore can protect pathogens

during routine cleaning and sanitizing. 

It is important that food processing establishments that are vulnerable to Cronobacter spp. or 

Salmonella spp. contamination maintain a food manufacturing environment that is not 

colonized by these organisms. 

 

Manufacturers or distributors who intend to distribute infant formula products in the United 

States must comply with applicable requirements in the FD&C Act and its implementing

regulations. The implementing regulations are summarized below. 

B. Section 412 of the FD&C Act 

The FD&C Act has a specific provision that establishes parameters under which an infant formula 

would be deemed adulterated. Section 412 of the FD&C Act (21 U.S.C. § 350a) states that an 

infant formula shall be deemed to be adulterated if it (1) does not provide the required nutrients; 

(2) does not meet the quality factor requirements; or (3) the processing of such infant formula is 

not in compliance with the good manufacturing practices and the quality control procedures. The 

requirements for nutrient content are set out in section 412(i) of the FD&C Act and in 21 CFR 

Part 107. The quality factor requirements, current good manufacturing practice (CGMP), and 

quality control procedures are described in section 412(b) of the FD&C Act and 21 CFR Part 106. 

C. 21 CFR Part 106 

Title 21 CFR Part 106 includes requirements for current good manufacturing practice (CGMP), 

quality control procedures, audits and audit procedures, quality factors, records and reports, and 

registration, submission, and notification requirements specific to infant formulas. 

• Subpart A provides the status and applicability of the regulations in Part 106 and 

definitions. 

• Subpart B contains comprehensive CGMP requirements for infant formula that 

establish a framework in which specific processes and control decisions are assigned 

to the infant formula manufacturer. The regulations specify the result to be achieved 

but do not prescriptively mandate how the manufacturer must achieve the result. 

• Subpart C includes quality control procedures that require each manufacturer to test 

in-process and finished infant formula to ensure that all nutrients required by 21 CFR 

107.100 and any other added nutrients are present at appropriate levels. Manufacturers 

are also required to conduct comprehensive stability testing for new infant formulas 

and routine stability testing for product subsequently produced. 
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• Subpart D identifies requirements for audit plans and procedures for infant formula 

manufacturers. 

• Subpart E establishes two quality factors (normal physical growth of infants and 

sufficient biological quality of protein) for infant formulas. 

• Subpart F includes records and reports requirements, including those for CGMPs, 

quality control procedures such as nutrient testing, audits, complaints, and quality 

factor requirements. 

• Subpart G includes infant formula registration, submission, and notification 

requirements.

In addition to the production requirements, the revision to Part 106 replaced the terms “batch” and 

“lot” with two new terms, “production aggregate” and “production unit.” The rule defines 

“production aggregate” and “production unit” in a manner that clarifies the volume of formula 

and stage of production represented by each term as well as the relationship between the two 

volumes of formula. FDA used these new descriptors to clarify the quantity of formula associated 

with the master manufacturing order and with the requirements for microbiological and nutrient 

testing. Production aggregate means a quantity of product, or, in the case of an infant formula 

produced by continuous process, a specific identified amount produced in a unit of time, that is 

intended to have uniform composition, character, and quality, within specified limits, and is 

produced according to a master manufacturing order. Production unit means a specific quantity of 

an infant formula produced during a single cycle of manufacture that has uniform composition, 

character, and quality, within specified limits. A production aggregate may consist of one or more 

production units. 

 

D. 21 CFR Part 107 

Title 21 CFR Part 107 includes labeling requirements, terms and conditions for exempt infant 

formulas, nutrient requirements, and information and requirements for infant formula recalls. 

Subpart A includes the status and applicability of the regulations in Part 107 as well as 

definitions. Subpart B provides information about labeling of infant formulas including how 

nutrients are to be listed, specific requirements for directions for use, and exemptions. Subpart B 

also includes the requirement for inclusion of a “Use by” date on the infant formula product (21 

CFR 107.20(c)). 

Subpart C establishes the terms and conditions for Exempt Infant Formulas, which are specialty 

infant formulas intended for use by infants with special medical and/or dietary needs. Section 412(h) 

exempts these infant formula products from meeting the requirements of sections 412(a), (b), and 

(c). However, FDA has published guidance recommending manufacturers of exempt infant formulas 

follow, to the extent practicable, 21 CFR Part 106, Subparts A, B, C, D, and F. See FDA Guidance 

for Industry, Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), 

Quality Control Procedures, Conduct of Audits, and Records and Reports, available at: 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm384

451.htm. 
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Subpart D provides the nutrient requirements for infant formula, which includes identification of 30 

required nutrients (minimum levels per 100 kilocalories for 30 nutrients and maximum levels for 10 

nutrients). It also provides additional requirements for specific nutrients. 

 

Subpart E establishes infant formula recall requirements that (1) specify mandatory recall 

procedures to be used by manufacturers in removing from the marketplace an adulterated or 

misbranded infant formula that the Agency has determined presents a risk to human health; (2) 

require a manufacturer recalling an infant formula that represents a risk to human health to 

request each retail establishment at which such infant formula is sold or available for sale to post 

a notice of such recall; and (3) establish requirements for retention of infant formula distribution 

records (54 FR 4006 ). The Food and Drug Omnibus Reform Act of 2022 included additional 

requirements related to infant formula recalls (see discussion below). 

E. 21 CFR Parts 108, 113, and 114 

In addition to complying with 21 CFR Parts 106 and 107, domestic and foreign manufacturers of 

low-acid and acidified liquid infant formulas must comply with the requirements specified in 21 

CFR Part 108 Emergency Permit Control, 21 CFR Part 113 Thermally Processed Low-Acid 

Foods Packaged in Hermetically Sealed Containers, and 21 CFR Part 114 Acidified Foods as 

applicable. These regulations address manufacturing, processing, and packing of these products to 

control microorganisms including Clostridium botulinum. When conducting inspections of infant 

formula that are also subject to Parts 108, 113, and 114, the Acidified and Low-Acid Canned 

Foods Program – Domestic and Import compliance program should be used as reference.

F. 21 CFR Part 117 

Infant formula manufacturers are also subject to the applicable requirements in 21 CFR Part 117. 

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls 

for Human Food final rule (CGMP & PCHF rule) includes requirements for current good 

manufacturing practices (primarily in Subpart B) and hazard analysis and risk-based preventive 

controls (primarily in subparts C and G). In general, the requirements for hazard analysis and riskbased preventive controls apply to domestic and foreign facilities that manufacture, process, pack, 

or hold food, including infant formula, for consumption in the United States and must register 

under section 415(a) of the FD&C Act. 

Facilities that are subject to the requirements for hazard analysis and risk-based preventive 

controls must prepare and implement a written food safety plan under Subpart C. The food safety 

plan begins with conducting a hazard analysis to identify and evaluate known or reasonably 

foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility 

to determine whether there are any hazards requiring a preventive control. The facility must also 

identify and implement written preventive controls, such as process controls, food allergen 

controls, sanitation controls, supply-chain controls, and a recall plan, as appropriate, to ensure that 

identified hazards are significantly minimized or prevented. Preventive controls are subject to 

preventive control management components including monitoring, corrective actions and 

corrections, and verification, as appropriate to ensure the effectiveness of the preventive controls. 
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Facilities are also required to document monitoring, corrective actions, and verification activities 

performed. Such records are subject to the requirements pertaining to records in Subpart F. 

The requirements pertaining to the supply-chain program are in Subpart G. A 

manufacturer/processor (i.e., a receiving facility) that relies on a supplier to control hazards 

associated with raw materials or other ingredients must establish and implement a supply-chain 

program that includes using approved suppliers and determining, conducting, and documenting 

supplier verification activities. The supply-chain program must provide assurance that any 

hazards requiring a supply-chain-applied control have been significantly minimized or prevented. 

In addition to preventive controls requirements, Part 117 also includes Current Good 

Manufacturing Practice requirements in Subpart B. Establishments subject to Subpart B, such as

infant formula facilities, must ensure that all requirements are met pertaining to personnel, plants 

and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, 

processes and controls, warehousing and distribution, holding and distribution of human food byproducts for use as animal food, and defect action levels. Infant formula facilities must meet the

CGMP requirements in 21 CFR Parts 106 and 117. 

21 CFR Part 117 also establishes in Subpart A requirements for all individuals engaged in 

manufacturing, processing, packing, and holding food to be qualified individuals and receive 

training in food safety and food hygiene. The training in food safety and food hygiene must be 

documented. 

G. Food and Drug Omnibus Reform Act of 2022 (PL 117-238) 

The Food and Drug Omnibus Reform Act of 2022 included several provisions related to infant 

formula. A few of the provisions are highlighted here. 

The law added new requirements related to infant formula recalls. Section 3401(g) amended 

section 412 of the FD&C Act. Under new 412(k) of the FD&C Act, FDA is required to notify 

Congress within 24 hours after the initiation of an infant formula recall under section 412(e) of 

the FD&C Act. The recall notification must include a summary of specific information related to 

the recall and an estimate of the disruption in the marketplace. Section 3401(h) of the Food and 

Drug Omnibus Reform Act of 2022 requires that after initiation of a recall, manufacturers submit 

a plan to FDA of the actions the manufacturer will take, including to identify and address the root 

cause and restore operation of the impacted facilities. Section 3401(i) of the Food and Drug 

Omnibus Reform Act of 2022 requires communication with the manufacturer after an inspection 

of a facility impacted by a recall, including a substantive response to any corrective actions 

submitted by the manufacturer. 

The law also added requirements related to inspections. Section 3401(i)(3) of the Food and Drug 

Omnibus Reform Act of 2022 requires an inspection of each domestic and foreign manufacturer 

every calendar year. Section 3401(i)(2) of the Food and Drug Omnibus Reform Act of 2022 

requires timely communication with an infant formula manufacturer following an inspection and 

requires timely reinspection to ensure corrective actions were accomplished. 
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Infant formula firms are now also required to develop, maintain and implement, as appropriate, 

risk management plans to identify and evaluate risks to the supply of the critical food, such as 

infant formula, and ways to mitigate such risks. This is a new requirement mandated by Congress 

in the Food and Drug Omnibus Reform Act of 2022. Additional information is forthcoming.
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PART II - IMPLEMENTATION

Objectives 

a) To conduct an annual inspection at each domestic and foreign establishment 

manufacturing infant formulas for the U.S. market to ascertain the firm’s compliance 

with the applicable requirements of the FD&C Act (e.g., sections 412 and 418) and 

FDA’s regulations under 21 CFR Parts 106, 107, 108, 113, 114, and 117. 

b) To collect samples of finished infant formula products at each domestic infant formula 

facility during annual inspection for nutrient analysis (liquid and powder forms) and 

microbiological analysis (powdered products only). 

c) To perform environmental sampling once a year at each domestic powder infant 

formula manufacturing facility during annual or compliance follow up inspection for 

both Cronobacter and Salmonella analysis if there are no significant adverse supplychain implications. 

d) To collect new and revised labels and labeling of infant formulas (i.e., labels and 

labeling that are new or have been revised since the last inspection).

e) To increase the collection of samples of foreign manufactured finished infant formula

products at the U.S. border, in import status for nutrient analysis (liquid and powdered 

products) and microbiological analysis (powdered products only) to ensure imported 

product is safe and comparable to domestically produced infant formula.

f) To ensure that imported infant formulas manufactured by firms that have not filed the 

required notifications under the Act are reviewed and examined as instructed in Part 

III of this compliance program.

g) To ensure that infant formulas offered for import as U.S. Goods Returned (USGR) are 

reviewed and examined as instructed in Part III of this compliance program. 

h) To document significant inspectional and violative sample findings and initiate 

regulatory action(s), as warranted.

Program Management Instructions

FDA requirements apply to both domestic and imported products. FDA is committed to ensure 

the safety and integrity of infant formula through: 

• annual inspections of all domestic and foreign facilities that manufacture infant 

formula for the U.S market, 

• sample collections of domestic and imported infant formula for nutrient and 

microbiological analyses, 

• appropriate compliance follow-up activities, and
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• appropriate import activities (entry review of admissibility requirements, import 

examinations, & sample collections) for imported infant formula. 

A. Inspection Priorities

FDA conducts annual inspections of all domestic and foreign facilities that manufacture infant 

formula for the U.S. market. CFSAN/Office of Nutrition and Food Labeling (ONFL) will 

notify CFSAN Office of Compliance (OC) when they complete the review of a submission by 

a manufacturer or distributor relative to a new infant formula before marketing the products in

U.S. commerce. The Office of Compliance along with the ORA Critical Foods Coordination 

Team schedule inspections at these facilities and include them in the annual infant formula 

inspection schedule. 

1. Domestic Inspections

CFSAN/ONFL shares the name and address of domestic infant formula facilities with 

CFSAN/Office of Compliance (OC) to schedule inspections. The annual infant formula 

inspection and sample collection schedule has the current list of domestic infant formula 

manufacturers in the U.S. that have undergone the required notification procedure. 

Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination 

Team prepares the annual inspection schedule that identifies and prioritizes the inspections 

of domestic infant formula firms based on: 

• the facilities’ previous inspection results 

• number of consumer complaints since the last inspection 

• number of violative samples collected by FDA in the last twelve months

• the previous environmental sampling results performed by FDA. 

The inspection and sample collection schedule for infant formula is issued in a separate 

memorandum to ORA Critical Foods Coordination Team and copy all OHAFO divisions 

prior to the start of each fiscal year. 

 

Email the Compliance Program Contacts in Part VI of this compliance program if 

difficulties in implementation are encountered. 

When CFSAN is notified of a new infant formula manufacturer, the ORA Critical Foods 

Coordination Team and the appropriate OHAFO division will be notified to conduct an 

unplanned inspection and/or sample collection at this facility. 

2. Foreign Inspections

The CFSAN/ONFL will provide ORA Office of Human and Animal Food Operations 

(OHAFO) the list of foreign infant formula facilities and their addresses. 

OHAFO/Division of Foreign Human and Animal Food Operations (DFHAFO) will follow 

their established procedures to schedule inspections at the foreign facilities. The name and 
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addresses of foreign infant formula facilities that have submitted the notification to 

CFSAN/ONFL are listed in Attachment C of this compliance program. 

Foreign inspections will not routinely include finished product sample collection for 

nutrient and/or microbiological analysis. Note: Please notify CFSAN 

Regulatory/Compliance Contacts immediately for further instructions if any of the foreign 

firm’s testing results for finished product(s) yield positive results for the targeted 

pathogens. The investigator should obtain a list of finished product(s) intended to be 

offered for import into the U.S. If the firm is no longer manufacturing infant formula, or 

no longer manufacturing infant formula that is intended to be offered for import into the 

U.S. market, this information must be documented and reported in the EIR. 

B. Planning Instructions

Before a new infant formula can be marketed in the United States, the infant formula 

manufacturer must provide FDA with a notification (i.e., new infant formula submission) 

about the proposed infant formula as required under section 412 of the FD&C Act. This 

premarket infant formula submission must contain detailed information about the formulation, 

an explanation of what has changed (if it is a reformulation), and nutritional and 

manufacturing assurances, and a demonstration that the formula meets the quality factor 

requirements. 

This compliance program covers inspections of domestic and foreign infant formula 

manufacturing firms, as well as sample collection and analysis of domestic and foreign 

manufactured infant formula products for Cronobacter and Salmonella spp. 

Environmental sample collections are planned at least once a year during annual, or 

compliance follow up inspections at each domestic powder infant formula facility for both 

Salmonella and Cronobacter analysis. 

C. Interaction With Other Compliance Programs (CP)

The following inspections may be conducted concurrently during an infant formula 

inspection. Time expended under the following (or other) compliance programs should be 

reported under the specific Program/Assignment Code(s) for those programs: 

a) Medical Foods - Import and Domestic Program, CP (7321.002)

Some infant formula manufacturers also manufacture medical foods. As a result, FDA 

may schedule an infant formula inspection and medical foods inspection to occur 

concurrently at such a manufacturing facility. 

b) Acidified and Low-Acid Canned Foods Program – Domestic and Import, CP 

In addition to 21 CFR Parts 106 and 107, manufacturers of liquid infant formulas are 

also subject to the requirements of 21 CFR Parts 108, 113 and 114 as applicable. 

Therefore, the inspection of liquid infant formula manufacturers should include 

assessing for compliance with these regulations. 
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c) Preventive Controls and Sanitary Human Food Operations, CP, (7303.040)

Infant formula manufacturers are subject to the CGMP requirements and the 

preventive controls requirements in 21 CFR Part 117. Inspections of infant formula 

manufacturers should primarily focus on compliance with 21 CFR Part 106. However, 

there are certain requirements in Part 117 that are not addressed in Part 106, therefore, 

compliance with those requirements will need to be assessed in accordance with CP 

7303.040. For specific information regarding requirements to be assessed under Part 

117, please see the Infant Formula Resource Page for “Parts 106/117 Citations Table”.

In addition, inspections at the manufacturers supplying nutrients premix to infant 

formula manufacturers will be conducted in accordance with CP 7303.040. Further, 

for Foreign Supplier Verification Requirements (FSVP), see CP 7303.878. 

D. Resource Instructions

Resources for inspections, sample collections, examinations, sample analyses, and any 

emerging issues for infant formula are provided in the ORA field workplan. Resources are 

allocated through a prioritization process by CFSAN and ORA.

E. Interactions with other Federal Agencies, State, and Local Counterparts, and Foreign 

Authorities

CFSAN, OHAFO, and Office of Import Operations (OIO) regularly coordinate with other 

government agencies (OGAs) to take enforcement actions. Agencies retain regulatory 

authorities but use differing procedures to execute enforcement actions. Primary enforcement 

authority may be deferred to the agency best equipped to maximize enforcement outcomes 

and benefit public health. 

For example, in the case of a U.S. Customs and Border Protection (CBP) seizure, any 

Customs officer may seize an imported article under U.S.C. Title 19, if there is reasonable 

cause to believe that any law or regulation enforced by CBP, Immigration and Customs 

Enforcement (ICE), or FDA has been violated. FDA may follow standard procedures in 

assisting CBP or Department of Homeland Security (DHS) in determining violations of the 

FD&C Act. 
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PART III – INSPECTIONAL

Operations

A. Inspections 

General Information

As established in the Food and Drug Omnibus Reform Act of 2022, the FDA must conduct annual 

inspections at all domestic and foreign infant formula manufacturing facilities required to be 

registered. Additionally, FDA must reinspect infant formula manufacturers in a timely manner if 

reinspection is needed to ensure the manufacturer completed any remediation actions or addressed 

any deficiencies. 

Inspections conducted under this compliance program should evaluate industry compliance with 

applicable regulations including 21 CFR Parts 106 and 107, and, as necessary, 108, 113, 114, and 

117. 

Refer to Infant Formula and Medical Food Inspection and Sample Collection Schedule for 

information on infant formula firms and their scheduled inspection dates. 

Email the CFSAN and ORA Compliance Program Contacts i) if an inspection cannot be 

completed as scheduled, ii) to obtain the plant report and to obtain information regarding ongoing 

activities pertaining to the facility.

See the Guide to Inspections of Manufacturers of Miscellaneous Food Products at 

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074988.htm for guidance in 

conducting inspections. For background information and knowledge on infant formula 

regulations take the online training, “Infant Formula Regulation Update” at ORA 

LearnED Training System. 

When appropriate and as resources permit, CFSAN and laboratory personnel will accompany the 

investigator during an infant formula firm inspection. 

When conducting inspections, investigations, recall effectiveness checks, or other operations 

directed by FDA compliance programs, be alert for products promoted as infant formulas 

but that may not meet the requirements of section 412 of the FD&C Act. Such products 

have, in the past, been found for sale in health food or natural food stores, in international food 

markets, or online. If products are found that are not on Attachment C and D of this compliance 

program, email the CFSAN Compliance Program Contacts with a copy of the label and labeling. 
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New Infant Formula or Significant Changes - Information for Attachment A

Attachment A must be completed and sent electronically to the CFSAN ONFL Infant Formula 

and Medical Foods Staff (IFMFS), see Part VI of this compliance program upon completion of 

the inspection. 

In advance of each inspection, CFSAN compliance program monitor will notify the ORA Critical 

Foods Coordination Team and copy the respective HAF division with a “plant report” that 

contains information about infant formula submissions received since the last inspection as well 

as any special requests for the FDA investigator. 

The regulation (21 CFR 106.120(a), (b) and (c)) requires manufacturers of infant formulas to 

submit notification when there are changes in formulation, processing, or packaging and for first 

production aggregate stability testing exemptions under 21 CFR 106.91(b)(1)(ii). Do not rely 

solely on CFSAN notification; the investigator must also ascertain this information from the firm. 

Specific questions for each of these items are included in Attachment A. 

At the beginning of each inspection, obtain information regarding new infant formulas and infant 

formulas with changes in formulation, processing, or packaging and complete Attachment A. 

Per 21 CFR 106.3, new infant formula means (1) an infant formula manufactured by a person (see 

also the definition of manufacturer in 21 CFR 106.3), that has not previously manufactured an 

infant formula, and 2) an infant formula manufactured by a person that has previously 

manufactured infant formula and in which there is a major change in processing or formulation 

from a current or any previous formulation produced by such manufacturer, or which has not 

previously been the subject of a submission under section 412(c) of the Federal Food, Drug, 

and Cosmetic Act for the U.S. market. For further information, see Regulations and 

Information on the Manufacture and Distribution of Infant Formula. 

Examples of the types of changes to be reported on Attachment A include the following (see the 

definition for “major change” in 21 CFR 106.3): 

a) Any infant formula produced by a manufacturer who is entering the U.S. market; 

b) Any infant formula powder processed and distributed by a manufacturer who 

previously only produced liquids (or vice versa); 

c) Any infant formula having a significant revision, addition, or substitution of a 

macronutrient (i.e., protein, fat, or carbohydrate), with which the manufacturer has not 

had previous experience; 

d) Any infant formula manufactured on a new processing line or in a new plant; 

e) Any infant formula manufactured containing a new constituent not listed in section 

412(i) of the FD&C Act (21 U.S.C. § 350a(i)), such as taurine or L-carnitine;

f) Any infant formula processed by a manufacturer on new equipment that utilizes a new 

technology or principle (e.g., from terminal sterilization to aseptic processing); or 

g) An infant formula for which there has been a fundamental change in the type of 

packaging used (e.g., changing from metal cans to plastic pouches). 
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The following items pertain specifically to the above submissions and should be submitted 

with the EIR to determine the significance of the change. The following is relevant, whether or 

not the firm has previously reported the change to the Agency, to verify that firms have reported 

the required data.

a) Results of analyses demonstrating compliance with 21 CFR 106.91(b) (shelf-life 

stability) must be obtained from the comprehensive stability testing required for new 

infant formulas and the routine stability testing required for subsequently produced 

formulas; (note: see section below on 106.91 requirements) 

b) Information on homogeneity must be collected when changes in processing occur that 

could affect the homogeneity of the formula, e.g., change in blending operations, 

change in point where nutrient is added, etc.; 

c) Compare the list of processing changes that CFSAN has provided with the list of 

processing changes the firm provides or that are observed during the inspection. Any 

differences or deviations must be documented in the EIR; and 

d) Refer to C. Sample Collection later in this Part for instructions on collecting samples.

Collection of labels and labeling 

 

Collect one original of product labels and labeling (e.g., promotional literature, brochures, 

physician letters, or web pages) that are new or revised since the last inspection. Note that 

labeling does not include coupons, samples, internal presentations, or promotional materials that 

are not intended to accompany the product at the point of sale; see the definition of labeling in 21 

CFR 1.3(a). Be aware that each product may be produced at different caloric levels; each of 

these labels should be considered a different product for the purpose of this program. Submit 

them along with the EIR. 

Determine if the firm has any related plants that spray dry, manufacture, or package infant 

formula. 

For manufacturers of finished product infant formulas, determine whether nutrient premixes are 

supplied by outside firms. Report the names and physical locations of all related plants and firms 

in the EIR. When inspecting firms that pasteurize, condense or spray dry infant formula 

ingredients, or dry blend infant formula ingredients, ensure that manufacturing procedures prevent

microbial contamination.

Review of Consumer Complaints Files During Inspection

Review consumer complaint files for the time-period since the last infant formula inspection, 

according to the following procedures. The below information should be included in the EIR. 

Additional information about manufacturers’ responsibilities concerning handling of complaints 

can be found in 21 CFR 106.100(k). 
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a) Review the complaint histories for all new or reformulated products. For reformulated 

products or products that have undergone a processing or packaging change, compare 

the complaint history for product before versus after the reformulation, process, or 

packaging change. 

b) For each formula and type (ready to feed, concentrate, powder), determine the number 

of complaints and the total number classified as possibly involving a health hazard. 

c) Report the basis used to determine whether or not a potential health hazard existed. 

d) For those complaints found to involve a potential health hazard, report how the firm 

followed up. 

e) Determine which three production aggregates of infant formula had the largest number 

of complaints involving a health hazard potential. Obtain a listing of those complaints 

with sufficient information to assess for trends. 

Records of Positive Results

Investigators should immediately notify CFSAN Regulatory/Compliance contact (see Part VI of 

this compliance program) if they encounter positive finished product sample results or positive 

environmental sample results during record review. 

Inspection for Compliance with Infant Formula CGMP Requirements

The investigator should cover the entire production and in-process control system 

established by the firm to ensure compliance with 21 CFR 106.5 through 106.90 (Subpart 

B). 

Under 21 CFR 106.6, manufacturers are required to implement a system of production and inprocess controls that covers all stages of processing. The system must be set out in a written plan 

or set of procedures that is designed to ensure that the infant formula is manufactured in a manner 

that will prevent adulteration and includes: 

• establishment of specifications and corrective action plan for when a specification is 

not met; 

• monitoring of the production and in-process control point, step, or stage; 

• documented reviews and material disposition decisions for articles not meeting a 

specification; 

• the quarantine of any article that fails to meet a specification pending completion of a 

documented review and material disposition decision; and

• establishment of recordkeeping procedures that ensure compliance with the 

requirements in 21 CFR 106.6. 
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Specific controls are required to prevent adulteration by 

• workers (106.10), 

• facilities (106.20), 

• equipment or utensils (106.30), 

• automatic (mechanical or electronic) equipment (106.35), and 

• ingredients, containers, and closures (106.40). 

Under 21 CFR 106.50, manufacturers are required to prepare and follow a written master 

manufacturing order that establishes controls and procedures for the production of an infant 

formula. In 21 CFR 106.55, manufacturers are required to implement controls that will prevent 

infant formula from adulteration with microorganisms. In addition, controls are specified to 

prevent adulteration during packaging and labeling (106.60) and on the release of finished infant 

formula (106.70). Infant formula must be coded with a sequential number that permits 

identification of the product, including the location where it was packed, and tracing of all stages 

of manufacture (106.80). See sections 7, 9, 10, and 11 of Subpart B in the Assessment of 

Compliance with Individual CGMP Requirements below. 

Note to investigators: The production aggregate number does not have to match the number on 

the package so long as the manufacturer is able to link them for traceability. 

Ascertain if coding information is used by the firm to control the finished product in the 

marketplace, and how the firm has outdated product removed from the marketing channels 

(manufacturing representative visit, retail store management, etc.). Determine disposition of 

outdated product and amount disposed of in the last year. 

Manufacturers of liquid products are required to comply with the procedures specified in 21 CFR 

Part 113 for thermally processed low-acid canned foods packaged in hermetically sealed 

containers and 21 CFR Part 114 for acidified foods. Because powdered infant formulas are not 

sterile products, testing is required for powdered infant formula at the final product stage, before 

distribution, for two microorganisms, Cronobacter spp. and Salmonella spp. See section 8 of 

Subpart B in the Assessment of Compliance with Individual CGMP Requirements below for 

information on review for compliance with the controls to prevent adulteration from 

microorganisms. 

Review approximately 7 days of production records for one infant formula. The record review 

should include all records related to CGMPs and quality control procedures required under 

Subpart F (106.100) and the provisions of Subpart B and Subpart C. 

Under 21 CFR 106.90, manufacturers are required to conduct regularly scheduled audits to 

determine whether their production of infant formula has complied with the CGMPs required 

under 21 CFR 106.5 -106.80. Manufacturers must provide investigators with access to records 

assuring that the audits are being conducted but are not required to provide the actual written 

reports of the audits. See 21 CFR 106.100(j) and section 12 of Subpart B in the Assessment of 

Compliance with Individual CGMP Requirements below for additional information on CGMP 

audit requirements. 
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Inspection for Compliance with CGMP and Preventive Controls for Human Food 

Requirements in 21 CFR Part 117: 

In addition to the Part 106 requirements, investigators should also assess compliance with certain 

requirements in Part 117, as applicable. These include:

CGMP requirements in 21 CFR Part 117 (Subparts A, B)

• Requirements in 21 CFR 117.4(b)(2) and 117.4(d) pertaining to training in food 

hygiene and food safety and documentation of that training 

• Requirements in 21 CFR 117.10 pertaining to unsecured jewelry; maintenance of 

gloves; storage of personnel belongings, eating food, chewing gum, drinking 

beverages, or using tobacco; hand sanitizing; and protection against contamination 

with perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the 

skin 

• Requirements in 21 CFR 117.20(a) pertaining to harborage, roads, yards, parking lots, 

drainage areas and waste treatment

• Requirements in 21 CFR 117.35(c) pertaining to pest control 

• Requirements in 21 CFR 117.95 pertaining to human food by-products for use as 

animal food 

• Requirements in 21 CFR 117.20(b) pertaining to plant construction and design, 

particularly outdoor bulk vessel storage and adequate screening against pests

Hazard Analysis and Preventive Controls requirements (Subparts C, F, and G)

• Requirements in 21 CFR 117.130 of Subpart C pertaining to conducting and having a 

written hazard analysis

• Requirements in 21 CFR Part 117, Subpart G pertaining to supply-chain preventive 

controls 

• Requirements in 21 CFR Part 117, Subpart F pertaining to hazard analysis and supplychain program records

The inspection team should cover supply-chain program requirements, when applicable, under 21 

CFR Part 117. Infant formula facilities must establish and implement a written supply-chain 

program if they receive raw materials or other ingredients where significant hazards are controlled 

by the supplier. The basic required components include: having a written supply-chain program; 

using approved suppliers; and determining, conducting, and documenting supplier verification 

activities to provide assurance that hazards requiring a supply-chain-applied control have been 

significantly minimized or prevented. 

“Parts 106/117 Citations Table” on the Infant Formula Resource Page provides information in the 

Notes column on when to cite under 21 CFR Part 117.
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Assessment of Compliance with Individual CGMP Requirements

Subpart B – Current Good Manufacturing Practice 

Specific determinations needed to assess whether manufacturers have complied with each 

requirement of the CGMP regulations in Subpart B (21 CFR 106.6-106.90) are listed below. 

1. Production and in-process controls system (106.6) 

A manufacturer is required to implement a system of production and in-process controls. The 

system shall cover all stages of processing, from the receipt and acceptance of the raw 

materials, ingredients, and components through the storage and distribution of the finished 

product and shall be designed to ensure that all the requirements of 21 CFR 106, Subpart B are 

met (21 CFR 106.6(a)). 

Investigators should determine and document whether: 

a. The manufacturer has a production and in-process control system set out in a written 

plan or set of procedures designed to ensure that an infant formula is manufactured in a 

manner that will prevent adulteration of the infant formula (21 CFR 106.6(b)). 

b. The manufacturer has established specifications; monitors the production and inprocess control point, step, or stage; has established a corrective action plan for use 

when a specification is not met; reviews the results of monitoring and when a 

specification is not met, a documented review shall be conducted by a qualified 

individual to make a material disposition decision to reject, reprocess, recondition, or 

release the article for use or distribution (21 CFR 106.6(c)). 

c. There is a quarantine system in place designed to prevent the use of an article that fails 

to meet a specification pending completion of the documented review and material 

disposition decision (21 CFR 106.6(c)). 

d. The manufacturer has the documentation and records of the monitoring at any point, 

step, or stage in the manufacturer’s production process where control is deemed 

necessary to prevent adulteration (106.100(e)(3)). Records to be reviewed include: 

i. A list of the specifications established at each point, step, or stage in the 

production process where control is deemed necessary to prevent adulteration 

including documentation of the scientific basis for each specification 

ii. The actual values obtained during the monitoring operation, any deviations from 

established specifications, and any corrective actions taken; and 

iii. Identification of the person monitoring each point, step, or stage in the 

production process where control is deemed necessary to prevent adulteration). 
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2. Controls to prevent adulteration by workers (106.10) 

Investigators should determine and document whether: 

a. The manufacturer employs sufficient personnel (qualified by education, training, or 

experience) to perform all operations, including all required record keeping, in the 

manufacture, processing, packing, and holding of each infant formula and to supervise 

such operations to ensure that the operations are correctly and fully performed (21 

CFR 106.10(a)). 

b. Personnel working directly with infant formula, infant formula raw materials, infant 

formula packaging, or infant formula equipment or utensil contact surfaces practice 

good personal hygiene while on duty to protect infant formula against contamination

(106.10(b)). Good personal hygiene, includes: 

i. Wearing clean outer garments and, as necessary, protective apparel such as 

head, face, hand, and arm coverings (106.10(b)(1)). 

ii. Washing hands in a hand washing facility with soap and running water at a 

suitable temperature before starting work, after each absence from the 

workstation, and at other times when the hands may become soiled or 

contaminated (106.10(b)(2)). 

c. The manufacturer has a process in place to prevent any person with an apparent illness 

or open lesions that may adversely affect the safety of infant formula from entering the 

production area until the condition is corrected or resolved. (106.10(c)). 

3. Controls to prevent adulteration caused by facilities (106.20) 

Investigators should determine and document whether: 

a. Buildings used in the manufacture, processing, packing, or holding of infant formula 

are in a clean and sanitary condition (106.20(a)). 

b. The manufacturer has adequate space for the separation of incompatible operations 

including handling of raw materials, the manufacture of the product, and packaging 

and labeling operations (106.20(a)). 

c. The manufacturer has separate areas or a system of separation (e.g., computerized 

inventory control, written card system, automated system of segregation) for holding 

raw materials, in-process materials, and final infant formula product at the following 

times (106.20(b)): 

i. Pending release for use in infant formula production or pending release of the 

final product;

ii. After rejection for use in, or as, infant formula; and

iii. After release for use in infant formula production or after release of the final 

product.
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d. There is adequate lighting that allows for the easy identification of raw materials, 

packaging, labeling, in-process materials, and finished products that have been 

released for use in infant formula product (106.20(c)). 

e. The lighting permits for the easy reading of instruments and controls necessary in 

processing, packaging, and laboratory analysis (106.20(c)). 

f. Lighting fixtures directly over or adjacent to exposed raw materials, in-process 

materials, or bulk (unpackaged) finished product have protection to prevent broken 

glass from contaminating the product in the event of breakage (106.20(c)). 

g. The manufacturer has adequate ventilation or control equipment, which may include 

the use of air filtration, to minimize odors and vapors in areas where they may 

contaminate raw materials, in-process materials, final product infant formula, packing 

materials, and infant formula-contact surfaces (106.20(d)). 

h. Rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing 

agents are stored and used in a manner that protects against contamination of infant 

formula (106.20(e)). 

i. The potable water used in the manufacture of infant formula meets the standards 

prescribed in the Environmental Protection Agency’s (EPA’s) Primary Drinking Water 

regulations in 40 CFR 141 (except that the water must not be fluoridated or must be 

defluoridated to a level as low as possible prior to use) (106.20(f)). 

i. The water supplied is under continuous positive pressure in a plumbing system 

that is free of defects, and there is no backflow from, or cross-connection 

between, piping systems that discharge wastewater or sewage and piping 

systems that carry water for infant formula manufacturing. 

ii. The manufacturer tests representative samples of the potable water drawn at a

point in the system in which the water is in the same condition as when used in 

infant formula manufacturing. 

iii. Review records (106.100(f)(1)) of the frequency and results of the potable 

water testing. The tests must be conducted no less than annually for chemical 

contaminants, every 4 years for radiological contaminants, and weekly for 

bacteriological contaminants. 

j. The manufacturer uses only culinary steam at direct infant formula product contact 

points and the culinary steam is in compliance with the 3-A Sanitary Standards, No. 

60903. The boiler water additives in the steam are used in accordance with 21 CFR 

173.310 (106.20(h)). 

k. The manufacturing site has readily accessible toilet and hand washing facilities that 

include hot and cold water, soap or detergent, single-service towels, or air dryers; the

facilities are sanitary, in good repair and allow for proper disposal of sewage; and the 

doors to the toilet facility do not open into areas where infant formula, ingredients, 

containers, or closures are processed, handled, or stored unless alternate means have 
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been taken to protect against contamination (106.20(i)). 

4. Controls to prevent adulteration caused by equipment or utensils (106.30) 

Investigators should determine and document whether: 

a. Equipment and utensils used in the manufacture, processing, packing, and holding of 

infant formula are:

i. Of appropriate design and installed to facilitate their intended function, 

cleaning, and maintenance (106.30(a)) and 

ii. Are constructed so that contact surfaces are made of nontoxic materials and are 

not reactive or absorptive (106.30(b)). 

b. The manufacturer uses equipment and utensils that are easily cleanable, are able to 

withstand the environment of their intended use and maintained to protect against 

contamination of infant formula (106.30(b)). 

c. The manufacturer ensures equipment and utensils used in the manufacture of infant 

formula are cleaned, sanitized, and maintained at regular intervals (106.30(f)). 

d. The manufacturer has an individual (qualified by education, training, or experience) 

who conducts reviews of all cleaning, sanitizing, and maintenance to ensure that it has 

been satisfactorily completed (106.30(f)(1)). 

e. The manufacturer maintains the records for equipment cleaning, sanitizing, and 

maintenance to document compliance with 106.100(f)(4) (106.30(f)(2)) including: 

i. The date and time of such cleaning, sanitizing, and maintenance; and

ii. The production aggregate number of each infant formula processed between 

equipment startup and shutdown for cleaning, sanitizing, and maintenance; and 

iii. The date and signature or initials of the person performing and checking the 

cleaning, sanitizing, and maintenance indicating that the work was done. 

f. The sanitizing agents used on the equipment and utensils that are regulated as pesticide 

chemicals under FD&C Act Section 408(a) comply with the Environmental Protection 

Agency’s regulations and if all other such sanitizers comply with applicable Food and 

Drug Administration laws and regulations (106.30(b)). 

g. The manufacturer has procedures, controls, or a system in place to ensure that any 

substance required for the operation of infant formula manufacturing equipment (e.g., 

lubricant or coolant) does not come in contact with formula ingredients, containers, 

closures, in-process materials, or with infant formula product during the manufacture 

of an infant formula (106.30(c)). 

h. The manufacturer has procedures, controls, or a system in place to ensure that each 

instrument used for measuring, regulating, or controlling mixing time and speed, 
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temperature, pressure, moisture, water activity, or other parameter at any point, step, or 

stage where control is necessary to prevent adulteration during processing is accurate, 

easily read, properly maintained, and present in sufficient number for its intended use 

(106.30(d)). 

i. Determine and document if the instruments and controls have been calibrated 

against a known reference standard at the time of or before first use and at 

routine intervals as specified by the manufacturer of the instrument or control.

ii. Review the records (106.100(f)(2)) of accuracy checks of instruments and 

controls. At a minimum, the records must specify the instrument or control 

being checked, the date of the accuracy check, the standard used, the calibration 

method used, the results found, any actions taken if the instrument is found to be

out of calibration, and the initials or name of the individual performing the test.

iii. Determine if the manufacturer has procedures for actions to take if calibration 

of an instrument shows failure to meet a specification. If so, determine and 

document if those procedures include a written evaluation of all affected 

product and any actions that need to be taken with respect to that product.

i. The manufacturer conducts thermal processing of infant formula packed in hermetically

sealed containers. If so, determine whether the equipment and procedures conform to 

21 CFR Parts 108 and 113 (106.30(e)(1)). 

i. Determine if the manufacturer monitors the temperature in thermal processing 

equipment at points where temperature control is necessary to prevent 

adulteration. 

ii. Determine if the monitoring is conducted at the frequency required by 

regulation or necessary to ensure temperature control is maintained. 

j. The manufacturer maintains all areas of cold storage at 40 °F (4.4 °C) or below 

(106.30(e)(2)(i)). If not, determine if the manufacturer maintains cold storage areas at 

a temperature no more than 45 °F (7.2 °C) and obtain documentation that shows the 

manufacturer has the scientific data or other information to demonstrate that the time 

and temperature conditions are sufficient to ensure that there is no significant growth 

of microorganisms of public health significance (106.30(e)(2)(ii)). 

k. Cold storage compartments and thermal processing equipment have easily readable, 

accurate temperature-indicating devices (106.30(e)(3)(i)). 

l. The manufacturer utilizes one of the following methods to ensure that the temperature 

of each cold storage compartment is maintained (106.30(e)(3)(ii). Review the 

associated temperature records (106.100(f)(3)). 

i. Monitoring the temperature on a temperature-indicating device and recording 

with such frequency as is necessary to ensure temperature control is maintained; 

ii. Equipping with one or more temperature-recording devices that reflects, on a 

continuing basis, the true temperature within the compartment; 
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iii. Equipping with a high temperature alarm that has been validated to function 

properly and records the temperature with such frequency as is necessary to 

ensure temperature control is maintained; or

iv. Equipping with a maximum-indicating thermometer that has been validated to 

function properly and records the temperature with such frequency as is 

necessary to ensure temperature control is maintained. 

m. The manufacturer has procedures, controls, or a system in place to ensure that 

compressed air or other gases that are mechanically introduced into infant formula, that 

are used to clean equipment, or that come into contact with a surface that contacts 

ingredients, in-process materials, or infant formula product do not contaminate the 

infant formula (106.30(g)). 

n. The manufacturer has a filter in place capable of retaining particles 0.5 micrometer or 

smaller, installed as close as possible to the end of the gas line that feeds gas into the 

space (106.30(g)). 

5. Controls to prevent adulteration due to automatic (mechanical or electronic) equipment 

(106.35) 

Investigators should determine and document whether: 

a. The manufacturer has written procedures to ensure (that at any point, step, or stage 

where control is necessary to prevent adulteration of infant formula) all hardware is 

routinely inspected and checked and that hardware that is capable of being calibrated is 

routinely calibrated (106.35(b)(1)). 

b. The manufacturer checks and documents the accuracy of input into and output 

generated by any system used in the production or quality control of infant formula 

(106.35(b)(2)). 

c. The manufacturer validates each system prior to the release for distribution of any 

infant formula manufactured using the system (106.35(b)(3)). 

d. The manufacturer revalidates following the modification and prior to the release for 

distribution of any infant formula manufactured using the modified system, when the 

system is modified (106.35(b)(4)). 

e. There is an individual who is designated to modify software and whether the 

manufacturer checks the modified software to ensure that infant formula that is 

produced or analyzed using the modified software is in compliance with CGMP and 

quality control procedures requirements (106.35(b)(4)). 

f. The manufacturer has records for mechanical and electronic equipment used in the 

production or quality control of infant formula that documents compliance with 

106.100(f)(5) (106.35(c)), including: 
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i. A list of all systems used with a description of the computer files and the 

defined capabilities and inherent limitations of each system;

ii. A copy of all software used; 

iii. Records that demonstrate installation, calibration, testing or validation, and 

maintenance of the systems used; 

iv. A list of all persons authorized to create or modify software; 

v. Records that document modifications to software, including the identity of the 

person who modified the software; 

vi. Records that document retesting or revalidation of modified systems; and 

vii. A backup file of data entered into a computer or related system. The backup 

file shall consist of a hard copy or alternative system, such as duplicate

electronic records, tapes, or microfilm, designed to ensure that backup data are 

exact and complete, and that they are secure from alteration, inadvertent 

erasures, or loss.

6. Controls to prevent adulteration caused by ingredients, containers, and closures (106.40) 

Investigators should determine and document whether: 

a. The manufacturer has written specifications for ingredients, containers, and closures 

used in manufacturing infant formula and follows written procedures to determine

whether all ingredients, containers, and closures meet these specifications (106.40(d)). 

b. An individual (qualified by education, training, or experience) conducted and 

documented a review and made and documented a material disposition decision to 

reject, reprocess or recondition, or approve and release the ingredient, container, or 

closure or the affected infant formula if any specification is not met (106.40 (d)). 

c. The manufacturer stores ingredients, containers, and closures in separate areas or with 

a system of segregation (e.g., computerized inventory control, written card system, or 

automated system of segregation) clearly designated for materials pending release for 

use, released for use, or rejected for use in infant formula production (106.40(e)). 

d. The manufacturer has a quarantine system in place designed to prevent the use of any 

ingredient, container, or closure that has been exposed to heat, air, or other condition 

that may adversely affect it until a documented review and documented material 

disposition decision can be made (106.40(e)(1)). 

i. Determine if the system specifies that any rejected ingredient, container, or 

closure be clearly identified as having been rejected and controlled under 

quarantine to prevent its use. 

ii. Determine if the system specifies that any ingredient, container, or closure that 

has not been manufactured, packaged, labeled, or held under conditions to 

prevent adulteration under section 402(a)(1) through (a)(4) of the Federal Food, 

Drug, and Cosmetic Act must not be approved and released for use. 
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e. The manufacturer has records for ingredients, containers, and closures used in the

manufacture of infant formula to document compliance with 106.100(f)(6) (106.40(g)), 

including: 

i. The identity and quantity of each lot of ingredients, containers, and closures;

ii. The name of the supplier; 

iii. The supplier’s lot numbers;

iv. The name and location of the manufacturer of the ingredient, container, or 

closure, if different from the supplier; 

v. The date of receipt;

vi. The receiving code as specified; and 

vii. The results of any test or examination (including retesting and reexamination) 

performed on the ingredients, containers, or closures; and the conclusions 

derived therefrom; and the disposition of all ingredients, containers, or 

closures.

7. Controls to prevent adulteration during manufacturing (106.50) 

Investigators should determine and document whether: 

a. The manufacturer has a written master manufacturing order that establishes controls 

and procedures for the production of an infant formula (106.50(a)). 

b. The manufacturer has established controls to ensure that each raw or in-process 

ingredient required by the master manufacturing order is examined by one person and 

checked by a second person, or system, to ensure that the correct ingredients and 

weights or measures are added (106.50(b)). 

c. The manufacturer has an established system of identification for the contents of all 

compounding and storage containers, processing lines, and major equipment used 

during the manufacture of a production aggregate of an infant formula (106.50(c)). 

d. The manufacturer has established controls to ensure that the nutrient levels required by 

21 CFR 107.100 are maintained in the formula, and that the formula is not 

contaminated with microorganisms (106.50(d)). Determine and document that the 

controls include the following: 

i. The mixing time, speed, temperature, and flow rate of product and other critical 

parameters to ensure the addition of required ingredients to, and the 

homogeneity of the formula (106.50(d)(1)); 

ii. The spray-drying process for powdered infant formula, including the filtering

of the intake air before heating, to prevent microbial contamination

(106.50(d)(2); 

iii. The removal of air from the finished product to ensure that nutrient 

deterioration does not occur (106.50(d)(3)); and 

iv. Each container of finished product is properly sealed (106.50(d)(4)). 
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e. The manufacturer has established controls that ensure equipment used at points where 

control is deemed necessary to prevent alteration is monitored, so that personnel will be

alerted to malfunctions (106.50(e)). 

f. The manufacturer has established controls for in-process material(106.50(f)) as 

follows: 

i. For any specification established in accordance with §106.6(c)(1) that a 

manufacturer fails to meet for in-process material, an individual qualified by 

education, training, or experience shall conduct a documented review and shall 

make a material disposition decision to reject the affected in-process material, 

to reprocess or otherwise recondition the affected in-process material, or to 

approve and release the affected in-process material for use or distribution; 

ii. Pending a documented review and material disposition decision, any in-process 

material that fails to meet any specification established in accordance with 

§106.6(c)(1) shall be clearly identified as such and shall be controlled under a 

quarantine system designed to prevent its use in manufacturing or processing 

operations until completion of the documented review and material disposition 

decision (106.50(f)(2)); 

iii. Any in-process material that has been reprocessed or otherwise reconditioned 

shall be the subject of a documented review and material disposition decision 

by an individual qualified by education, training, or experience to determine 

whether it may be released for use (106.50(f)(3)); and

iv. Any rejected in-process material shall be clearly identified as having been 

rejected for use in infant formula and shall be controlled under a quarantine 

system designed to prevent its use in infant formula manufacturing or 

processing operations (106.50(f)(4)). 

8. Controls to prevent adulteration from microorganisms (106.55) 

Investigators should determine and document whether: 

a. The manufacturer has an established system of process controls covering all stages of 

processing that is designed to ensure that infant formula does not become adulterated 

due to the presence of microorganisms in the processing environment (106.55(a)). 

b. The manufacturer of liquid infant formula complies with the procedures specified in 21 

CFR Part 113 for thermally processed low-acid foods packaged in hermetically sealed 

containers and 21 CFR Part 114 for acidified foods (106.55(b)). 

c. The manufacturer tests representative samples of each production aggregate of 

powdered infant formula at the final product stage (before distribution) to ensure each 

production aggregate meets the microbiological quality standards. Determine and 

document whether the manufacturer is following the sampling requirements for 

Cronobacter spp. and Salmonella spp. (106.55(c)).
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d. The manufacturer has the records for the testing of powdered infant formulas for 

microorganisms to determine and document compliance with 106.100(e)(5)(ii) and 

(f)(7) (106.55(d)), including: 

i. The results of any testing conducted to verify compliance with the

microbiological quality standards in 106.55(e). Any powdered infant formula

with a test result of greater than zero for Cronobacter spp. or Salmonella spp. 

must be deemed adulterated. 

ii. A full description of the methodology used to test powdered infant formula to 

verify compliance with the microbiological quality standards. 

9. Controls to prevent adulteration during packaging and labeling of infant formula (106.60) 

Determine and document that the manufacturer has procedures, controls, or a system in place 

to examine packaged and labeled infant formula during finishing operations to ensure that all 

containers and packages in the production aggregate have the correct label, the correct use-by 

date, and the correct traceability code. 

10. Controls on the release of finished infant formula (106.70)

Determine and document that the manufacturer has a quarantine system designed to prevent 

the distribution of each production aggregate of infant formula until it determines that the

production aggregate meets all of the manufacturer’s specifications.

11. Traceability (106.80) 

Determine and document that the manufacturer codes each production aggregate with a 

sequential number that identifies the product and the establishment where the product was 

packed and that also permits tracing of all stages of manufacture.

12. Audits of current good manufacturing practice (106.90)

Investigators should determine and document whether: 

a. The manufacturer conducts regularly scheduled audits to determine compliance with 

CGMP regulations. 

b. The individual or team conducting the audits has any direct responsibility for the 

matters that the individual or team is auditing or have any direct interest in the

outcome of the audit. The audit must be unbiased. 

Inspection for Compliance with Infant Formula Quality Control Procedures Requirements

Subpart C – Quality Control Procedures 

The investigator should cover the quality control procedures established by the firm to ensure 

compliance with 21 CFR 106.91. 
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1. At times, records of analyses required by the Infant Formula Quality Control Procedures are 

not available at the plant being inspected but are located in a centralized facility doing the 

quality control analyses. If analytical records are not available at the plant being inspected, 

request that the firm obtain the records from the centralized facility for inclusion with the 

inspection report. If the firm is uncooperative in making this request, report this in the EIR, 

and submit a request for these records to the ORA Inspectional Contact(s), see Part VI of this 

compliance program, so they can facilitate the collection of records from the centralized 

facility location. 

2. Verify that testing for each nutrient required by 21 CFR 107.100 and any other nutrients 

added by the manufacturer in every production aggregate occurs prior to product entering 

interstate commerce. Document the firm’s nutrient testing procedures for the product(s) 

covered during the inspection on Attachment B. Obtain any data the firm has on stability 

testing of their infant formulas as described below for Subpart C. 

3. Review manufacturers quality control and audit procedures, and records of exempt infant 

formulas. For exempt infant formulas, FDA has posted guidance that recommends that 

manufacturers of exempt infant formulas follow, to the extent practicable, Subparts A, B, C, 

D, and F of 21 CFR Part 106. 

Assessment of Compliance with Individual Requirements for Quality Control Procedures

Specific determinations that are needed to assess whether manufacturers have complied with each 

requirement of the Quality Control Procedures regulations in Subpart C (21 CFR 106.91 and 

106.92) are listed below. 

1. General quality control (106.91) 

Per 106.3, the term nutrient means any vitamin, mineral, or other substance or ingredient that 

is required in accordance with the “Nutrients” table set out in section 412(i)(1) of the Federal 

Food, Drug, and Cosmetic Act or by regulations issued under section 412(i)(2) or that is 

identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine 

through its development of a Dietary Reference Intake, or that has been identified as essential 

for infants by the Food and Drug Administration through a Federal Register publication. 

Investigators should determine and document whether: 

a. The manufacturer tests each production aggregate, during manufacture, for nutrients as 

follows (106.91(a)): 

i. Each nutrient in each nutrient premix used in the manufacture of infant formula 

that the manufacturer is relying on the premix to provide.

ii. During the manufacturing process, after the addition of the premix, or at the

final product stage (but before distribution), at least one indicator nutrient for 

each of the nutrient premixes.

iii. At the final product stage (but before distribution), vitamins A, C, E, and 

thiamin.
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iv. During the manufacturing process or at the final product stage (but before 

distribution), all nutrients required to be included under 107.100 and any 

nutrient added by the manufacturer for which testing has not already been 

conducted under 106.91(a)(1) or (a)(3). 

b. The manufacturer tests each production aggregate of finished product for nutrients as 

follows (106.91(b)): 

i. For a new infant formula, the manufacturer tests a representative sample of the 

first production aggregate of each physical form for the levels of all nutrients 

required under 107.100 and all other nutrients added by the manufacturer. The 

testing required by 106.91(a) can serve as this initial final product testing 

requirement.

o Determine if the manufacturer has procedures in place to repeat the

testing every 4 months throughout the shelf life of the product. (Note: 

testing for minerals is not required here.) 

o If not, determine if the manufacturer has an exemption under 

106.91(b)(1)(ii) from FDA that exempts them from the requirement of 

conducting nutrient testing every 4 months for the first production 

aggregate of a new infant formula. 

ii. The manufacturer tests a representative sample of each production aggregate of 

finished product of infant formula in each physical form for the levels of all 

nutrients required under 107.100 and all other nutrients added by the 

manufacturer. The testing required by 106.91(a) can serve as this initial final 

product testing requirement. 

iii. The manufacturer repeats such nutrient testing at the end of the shelf life of 

the product. 

Note: Infant formula manufacturers may individually request enforcement discretion from the 

end-of-shelf-life nutrient testing requirement for each production aggregate. If granted, the 

manufacturer must be able to provide evidence of enforcement discretion to the investigator. 

c. The manufacturer has procedures to follow if the nutrient testing results show that any 

required nutrient is not present in the production aggregate at the level required by 

107.100 or that any nutrient added by the manufacturer is not present at the level 

declared on the label. Determine if these procedures require the manufacturer to do 

the following (106.91(b)(4)): 

i. Investigate the cause of the variance in the nutrient level); 

ii. Evaluate the significance of the results for other production aggregates of the 

same formula that have been released for distribution); 

iii. Address all production aggregates released and pending release for distribution 

that are implicated by the test results); and 

iv. Determine whether it is necessary to conduct additional testing. 
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d. The manufacturer conducts all quality control testing using appropriate, scientifically

valid test methods (106.91(c)). 

e. The records of all nutrient testing performed on the production aggregate of infant 

formula, including testing performed in-process, at the final product stage, on the

finished product, and throughout the shelf life documents compliance with 

106.100(e)(5)(i) (106.91(d)). These records must include: 

i. The results of all testing to verify that each nutrient required by 107.100 is 

present in each production aggregate of infant formula at the level required and 

that all other nutrients added by the manufacturer are present at the appropriate 

level;

ii. A summary document identifying the stages of the manufacturing process at 

which the nutrient analysis for each required nutrient is conducted; and 

iii. A summary document on the stability testing program conducted including the 

nutrients tested and the frequency of nutrient testing throughout the shelf life of 

the product. 

2. Audits of quality control procedures (106.92):

Investigators should determine and document whether: 

a. The manufacturer conducts regularly scheduled audits to determine compliance with 

requirements for quality control procedures necessary to ensure that an infant formula

provides the required nutrients. 

b. The individual or team conducting the audits has any direct responsibility for the 

matters that the individual or team is auditing or have any direct interest in the

outcome of the audit. The audit must be unbiased. 

Inspection for Compliance with Infant Formula Quality Factors Requirements

Subpart E — Quality Factors 

Eligible Infant Formulas

Determine and document if the manufacturer has made and is retaining records required under 21 

CFR 106.96(i)(5) to demonstrate that each of its “eligible” infant formulas (an infant formula that 

could have been or was lawfully distributed in the United States on December 8, 2014 (106.3)) 

supports normal physical growth in infants when fed as the sole source of nutrition and that the 

protein is of sufficient biological quality. The records demonstrating normal physical growth and 

protein quality required under 106.96(i)(5) are to be made and retained in accordance with 

106.100(p)(2) and 106.100(q)(2), respectively. 

Copy (as authorized under 106.100(l)) the manufacturer’s records required under 21 CFR 

106.96(i)(5) and send to the Infant Formula and Medical Foods Staff (IFMFS) for review to 

evaluate whether the records comply with the requirements of 106.96(i). If these records have 

already been provided to the IFMFS from a previous inspection, they do not need to be sent again.
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New Infant Formulas that are not Eligible Infant Formulas

Determine and document that the manufacturer has made and is retaining records required under 

21 CFR 106.96(d) demonstrating that each of its new infant formulas that is not an eligible infant 

formula meets the quality factor of normal physical growth. These records are to be made and 

retained in accordance with 106.100(p)(1) and must include records of a growth monitoring study 

conducted in compliance with the requirements of 106.96(b) or records demonstrating satisfaction 

of an applicable exemption under 106.96(c). 

 

Determine and document that the manufacturer has made and is retaining records required under 

21 CFR 106.96(h) demonstrating that each of its new infant formulas that is not an eligible infant 

formula meets the quality factor of sufficient biological quality of the protein. These records are 

to be made and retained in accordance with 106.100(q)(1) and must include records of an 

appropriate modification of the Protein Efficiency Ratio (PER) rat bioassay in compliance with 

the requirements of 106.96(f) or records demonstrating satisfaction of an applicable exemption 

under 106.96(g). 

Note: Infant formula manufacturers are required to submit, as part of a new infant formula 

submission, the scientific evidence to demonstrate that the formula meets the quality factor 

requirements or request an applicable exemption and submit the required information for the 

exemption. This information is reviewed by the IFMFS in CFSAN. 

 

Inspection for Compliance with Infant Formula Records and Reporting Requirements

Subpart F — Records and Reports

See “Infant Formula Records and Reports Inspection Aid” document for a list of all the records 

requirements. 

 

See above sections on inspections for CGMP, Quality Control Procedures, Audit Procedures, and 

Quality Factors for specific information on reviews of records during audits. 

Inspections of Foreign Manufacturers

The following information must be obtained during foreign inspections in order to assist in 

identifying future shipments offered for import into the U.S., should inspectional or analytical 

results warrant additional action:

a) The exact products/brands being exported to the U.S; 

b) The means of shipment (e.g., air, sea, truck); 

c) The size and frequency of the shipments;

d) The importer(s) of record for the shipments;

e) The U.S. ports where the products are offered for entry; and 

f) A list of the U.S. distributors, if available.

The infant formula manufacturer is required to have records for distribution under 106.100(g). 

Verify the U.S. exporter by reviewing the manufacturer’s records. 
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Inspections of Exempt Infant Formula Manufacturers

Review CGMPs, quality control (QC) and audit procedures, and manufacturer’s records. 

FDA has issued guidance recommending that manufacturers of exempt infant formulas follow, to 

the extent practicable, the General Provisions (Subpart A), CGMPs (Subpart B), Quality Control 

Procedures (Subpart C), Conduct of Audits (Subpart D), and Records and Reports (Subpart F) of 

21 CFR Part 106 as amended by the final rule published on June 10, 2014, in the production of 

their formula products. See Guidance for Industry: Exempt Infant Formula Production 

(APRIL 2016). However, because exempt infant formula is not required to meet the processing 

requirements in Part 106, exempt infant formula manufacturers must not be cited under part 106, 

except if the manufacturer failed to provide notice of adulteration or misbranding as required 

under 21 CFR 106.150. Observations at facilities that only manufacture exempt infant formulas 

must be cited under 21 CFR Part 117. 

Follow up and document any observations that indicate that the formula may contain nutrient(s) 

that it is specifically formulated not to contain.

B. Import Operations

Import activities may include examination, sample collection, or both to verify imported 

formula meets FDA regulatory requirements. 

In the absence of specific instructions outlined in an assignment or other directive, use the 

information below. 

1. Summary of Admissibility Requirements

The FDA will verify compliance with the following requirements at the time of import, as 

applicable:

a) Manufacturers are registered in accordance with section 412(c)(1)(A) of the FD&C

Act. 

 

b) Manufacturer(s) and distributor(s) have submitted information as required by 

section 412(d)(1) of the FD&C Act (The firms that have met the requirements in 

(a) and (b) are listed on Attachment C of this compliance program).

c) Infant formula manufacturers that do not meet the above requirements (and are not 

on Attachment C) or are not on the FDA enforcement discretion list may be 

subject to Detention Without Physical Examination (DWPE) to prevent the 

importation of products from non-notified facilities.

 

d) Product must be labeled in accordance with 21 CFR Parts 101, 107 and 403(w) of 

the FD&C Act. 
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e) Exemptions and Special Considerations 

i. Specialty infant formulas, intended for use by infants with special medical 

and dietary needs, see 21 CFR Part 107 Subpart C - These products should 

be reviewed according to requirements for conventional foods. 

ii. Infant formula for personal use - FDA typically does not object to the 

personal importation of infant formula that meet the criteria outlined in the 

Regulatory Procedures Manual (RPM) Chapter 9, Subchapter 9-2: 

Coverage of Personal Importations. 

iii. USGR must meet all applicable regulatory requirements. Typically, reasons 

for returning U.S. manufactured infant formula include quality issues, 

overstock, product recalls, or packaging and/or labeling issues. 

o USGR must be returning to the original manufacturer. 

o Manufacturers who produce infant formula product for export only 

must meet requirements as outlined in 21 CFR 106.120(c) including 

affirmation that the product will not be sold or offered for sale in 

domestic commerce.

f) Infant formula offered for import does not appear on the list of products in Import 

Alert #40-05 “Detention Without Physical Examination of Infant Formula Due to 

Failure to Meet Nutrient and Labeling Requirements”. The products listed have 

either been analyzed by FDA and fail to meet the nutrient requirements applicable 

to infant formula as specified in 21 CFR 107.100 or were found to be misbranded 

due to labeling violations. 

2. Import Entry Review

Entry review should be performed in accordance with the Investigations Operations 

Manual (IOM) Entry Review and the Import Summary of Admissibility Requirements 

section above. 

a) Verify infant formula products (finished or base powder) meet or are exempt from 

associated admissibility requirements. 

 

b) Assign a label examination (LEX/LBL) when: 

i. USGR are not consigned to the original manufacturer which must be listed 

on Attachment D. 

ii. entry/line is flagged for label examination within the import system. 

c) Assign a sample collection when entry/line is part of a sample collection 

assignment. 

3. Import Examinations 

a) Examinations should be conducted in accordance with the IOM 6.4, Field 

Examination. 
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b) When conducting label examinations verify: 

i. that the imported product and manufacturer matches the product and 

manufacturer listed on Attachment C or Attachment D.

ii. the product is labeled in accordance with 21 CFR 101.2, 101.3,101.4, 

101.5, 101.7, 101.15, and 107.20, and 403(w) of the FD&C Act. 

iii. If the label does not reveal any apparent violations, a sample may be 

collected during the examination (see Import Sample Collection below). 

c) Special Considerations for all USGR, including export only formula: 

i. Determine the intended disposition of the shipment once in domestic 

commerce (for example, commercial distribution, charitable donation, 

return for testing, etc.); 

ii. Collect evidence to document any violation and the reason the product is 

being returned to the U.S. 

4. Import Sample Collection

Imported infant formula surveillance samples will be collected while in import status, as 

warranted. Contact the CFSAN compliance program monitor(s) to determine if there are 

any supply chain concerns prior to any sampling. 

a) Samples of infant formula should only be collected when: 

i. requested by CFSAN compliance program monitor 

ii. instructed by an assignment, 

iii. identified by import system screening, or 

iv. adverse finding(s) is observed during an examination. Adverse conditions 

that warrant laboratory analysis may include in-transit or storage damage, 

concerns regarding inadequate storage temperature conditions, strange 

odors, and/or evidence of over-labeling. 

b) Samples should be collected in accordance with the IOM Section 6.5-Import 

Sample Collection. 

 

c) Method of Collection - Samples should be collected and labeled in accordance 

with IOM Chapter 4: Sampling. 

 

d) Sample Size - See Section D “Sample Size” of this compliance program. Sample 

Size - See Section C “Sample Size” of this compliance program.

e) Possible sample collections are outlined in “FIELD REPORTING 

REQUIREMENTS”
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C. Sample Collection (During Domestic Inspection)

The samples collected under this compliance program are collected in accordance with the 

separate inspection and sample collection schedule issued annually by CFSAN Office of 

Compliance. However, additional compliance samples should be collected as warranted by 

inspectional findings. 

In general, attempt to collect different products from those collected in recent inspections. 

Collection of products designed for healthy, full-term infants (i.e., non-exempt infant formula) 

should be given priority. However, products indicated for treatment of infant health 

conditions, such as inborn errors of metabolism and low birth weight (exempt infant 

formulas), can also be collected. If inspectional evidence indicates that an exempt infant 

formula may contain a nutrient(s) that it is specifically formulated to not contain, document 

the evidence and collect an official sample for laboratory confirmation. 

If only bulk product is manufactured by the firm being inspected, submit a request for sample 

collection to the OHAFO division where the finished product is packaged.

Attempt collection from the most recent production date of a production aggregate released by 

the firm’s quality control unit. Note the production date on Collection Reports. 

If surveillance activities disclose products which are promoted as infant formulas and which 

do not appear to meet the requirements of section 412 of the FD&C Act, collect one sample 

for nutrient analysis as described under the section titled: “Samples for Nutrient Analysis” 

below. 

If a new or reformulated infant formula product is encountered or the firm has introduced 

changes in its processing, determine if a premarket notification for this product was submitted 

to CFSAN. 

Collect a sample of each new or reformulated product, or product manufactured with revised 

processing procedures. If more than 1 or 2 new or reformulated products are encountered, 

contact the Infant Formula Program Contacts (see Part VI) for assistance in prioritizing the 

sample collections. Follow the sampling guidance below and sample each new or 

reformulated infant formula for nutrient analysis and, in the case of powders, microbiological 

analysis. When collecting samples of new or reformulated infant formula or products 

manufactured with revised processing procedures, make certain to flag the collection report as 

such. 

When samples are collected under this program at the owner named on the label or his agent, 

a 702(b) portion will not be required (see IOM 4.3.3.2). Firms should be encouraged to 

collect their own portion for analysis. If necessary, consult with your supervisor and/or the 

program monitor for further instructions. 

Prior to sample collection, email CFSAN Compliance Program Contacts to check any supply 

chain issues that may warrant modifying the sampling plan. 
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After the inspection has been initiated, but prior to collecting samples, determine the firm's 

policy with respect to FDA standard sampling procedures and solicit the firm’s cooperation. 

If firms do not permit backfilling, determine sample cost and obtain approval of the OHAFO 

division office prior to sampling. 

For domestic samples, follow the infant formula inspection and sample collection schedule

issued by CFSAN to determine the number and types of formulas to be sampled. 

Sample Collection During Foreign Inspection 

Finished product samples of infant formula produced by foreign manufacturers are not 

expected to be collected during foreign inspections. Foreign manufactured finished product 

samples are expected to be collected at the time of import. However, if warranted, additional 

sampling will be considered during a foreign facility inspection on a case-by-case basis 

following discussion with CFSAN. See Import Sample Collection under Import Operations 

above. 

 

Environmental Sample Collection

Environmental sampling will be conducted at each domestic powder infant formula facility at 

least once annually and may be collected during annual or compliance follow up inspection to 

(1) evaluate the firm’s processes and procedures to control Cronobacter and Salmonella in the 

processing environment; and (2) conduct environmental sampling to determine whether or not 

these bacteria are present in the food processing environment of these plants and thus present 

a risk of product contamination. 

During the inspection, collect environmental samples in accordance with SOP-001052 d IOM

subchapters 4.3.6.6, 4.3.6.6.1, 4.3.6.6.2 and C.P. 7303.050, Sampling for Foodborne 

Biological Hazards and Filth, Domestic and Import, while focusing on dry production areas 

after the final “kill step”. 

Environmental sampling should focus on zone two sites near potential product exposure 

points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into 

drying system, filling lines, blending equipment, raw material handling equipment, etc.) 

including any areas indicating water accumulation. Additional sampling should also be done 

from zone three sites, which may suggest a route of contamination (i.e., doorways, traffic 

routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites 

should not be swabbed as these zones can be hard to reach and may introduce contamination 

during swabbing of a closed system. Unless conditions observed indicate a possible route of 

contamination, we would not recommend swabbing zone four areas at a high frequency.

General Swabbing Areas for Consideration: 

• Ceilings, walls, floors, or other surfaces where moisture, leaks, or condensation 

is observed or where it appears there was moisture or a leak that had dried up 
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• Inspection doors, hatches, or other entryways used by the firm to gain access to 

the inside of enclosed production equipment 

• Support equipment (e.g., auto-samplers, ladders, lifts, fans, hoists, scales, 

removable steps, stools, forklifts, pallet jacks, supply cabinets, tools, air intake 

vents and filters, air supply vents, etc.)

• Cracked and/or exposed pipe insulation, if any 

• Sanitation tools and equipment used in post-kill step powder production areas 

(e.g., brushes, squeegees, mops, vacuums, floor scrubbing machines, water 

hoses, compressed air hoses, retractable hose reels, etc.)

Collect between 100-300 environmental swabs for Cronobacter spp. and collect 100-300 

environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility. 

Use the “Remarks” section of the collection report to identify the zone from which the 

subsamples (subs) were collected.

D. Sample Size

1. Nutrient analysis 

 Samples of the finished product will be collected at the manufacturing plant. 

Each sample (domestic or import) designated for nutrient analysis by Nutrient Analysis 

Branch (NAB) is to consist of the following: 

a) For one (1) pound powders and eight (8) oz. liquids, collect one (1) sub from each 

of twelve (12) randomly selected shipping cases. 

b) For 2 or 3 oz ready-to-feed units, such as Nursettes, collect eight (8) units from 

each of twelve (12) randomly selected shipping cases. The units from each 

shipping case may or may not be banded together into 4 packs for distribution. 

c) For larger (2.5/5 lbs.) powders and thirty-two (32) oz. liquids, collect one (1) sub

from each of twelve (12) randomly selected shipping cases. 

d) When more than one sub is collected per case, add a letter designation to the sub 

number (i.e., a, b, c, or d). This will ensure that the portion of the sample analyzed 

includes product from each case sampled. 

2. Microbiological analysis 

All finished dried product infant formula samples (domestic or import) designated for 

microbiological analysis, collect one sample from each production aggregate. 
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Microorganism Number of 

samples

Number of 

sub samples

Sample 

size/sub

Total 

amount/sample

Salmonella 1 60 25 g (grams) 1,500 (grams)

Cronobacter 1 30 10 g (grams) 300 (grams)

a) For Salmonella analysis, each sample should consist of a total of 60 cans (for 60 

subs) and each sub sample should consist of twenty-five grams (25 g) or larger. 

b) For Cronobacter analysis, each sample should consist of a total of 30 cans (for 30 

subs) and each sub sample should consist of ten grams (10 g) or larger.

NOTE: i) If the sample is collected for both Salmonella and Cronobacter analyses, 

then the sample amount (60 cans/25 g each) collected for Salmonella

analysis can also be used to perform Cronobacter analysis. 

ii) Do not submit commercially sterilized products, such as low acid canned 

foods, for microbiological analysis unless processing records or the 

appearance of the product containers indicate the product may be 

microbiologically contaminated.

c) For dry blended products, collect 1 sample (60 subs) of finished product and 1 

sample (60 subs) of a principal raw material ingredient from each production 

aggregate used in that finished product. When possible, collect an ingredient from 

the same production aggregate used in the manufacture of the sampled finished 

product. Collect samples from bulk containers of raw material ingredient using 

aseptic technique in accordance with IOM Section 4.3.6. Examples of ingredients 

to be collected include soy powder, nonfat dry milk, dried whey, delactosed whey, 

demineralized whey, whey protein concentrate, and caseinates. Before collecting 

carbohydrate or starch-, investigators should consult with the ORA/OHAFLO 

Methods Contacts /Microbiological Analysis (see Part VI of this compliance 

program). 

NOTE: Since sample requirements are different for the nutritional analysis and 

microbiological analysis of infant formula samples, separate samples shall be 

obtained for each.

E. Sample Shipment

Finished products and environmental samples for microbiological analysis may be 

shipped to any of the following servicing laboratories. Samples for nutrient analysis 

may only be shipped to the ATLHAF laboratory. Please refer to the LST dashboard for 

assistance in selecting a servicing lab. 
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Send samples to:

Food and Drug Administration 

Atlanta Human and Animal Food Laboratory (ATLHAF) 

60 8th Street, NE

Atlanta, Georgia 30309 

Food and Drug Administration 

Arkansas Human and Animal Food Laboratory (ARLHAF) 

3900 NCTR Rd. Bldg 26 

Jefferson, AR 72079 

Food and Drug Administration 

Denver Human and Animal Food Laboratory (DENLHAF) 

6th Ave and Kipling St. 

Building 20, Entrance W-10 

Denver, CO 80225 

Food and Drug Administration 

New York Human and Animal Food Laboratory (NYLHAF) 

158-15 Liberty Ave. 

Jamaica, NY 11433 

Food and Drug Administration 

Seattle Human and Animal Food Laboratory (SEAHAF)

22201 23rd Dr. SE

Bothell, WA 98021-4421 

Food and Drug Administration 

San Francisco Human and Animal Food Laboratory (SANLHAF) 

1201 Harbor Bay Pkwy. 

Alameda, CA 94502 

Food and Drug Administration 

Irvine Human and Animal Food Laboratory (IRVLHAF) 

19701 Fairchild Rd. 

Irvine, CA 92612 

Shipping of Environmental Samples: 

Divisions must provide advanced notice to laboratory management (>2 days) of the upcoming 

swab collection to ensure the laboratories have sufficient supplies available for analysis. Field

inspection staff must notify the analyzing laboratory via e-mail prior to shipping samples. The 
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e-mail must contain the sample number(s), the name of this compliance program, storage 

conditions required, the FACTS number, and sample tracking information. Contact the 

analyzing lab directly if there are any questions related to the analysis. 

Samples should be shipped by UPS “Next Day Air Early A.M.” to ensure arrival at the 

servicing laboratory within 24 hours. Samples may be shipped Monday through Thursday. Do 

not ship samples on Friday. Samples should be stored refrigerated prior to shipment. Ship 

samples in an insulated transport container with frozen gel packs to keep the samples cold, but 

not frozen. Field inspection staff may choose to separate samples from the frozen gel packs 

using cardboard or other material to prevent direct contact and freezing of sample broth. 

 

Reporting

a) Report EIR for both domestic and foreign inspections into eNSpect. 

b) Collect product labels and labeling (e.g., promotional literature and brochures) that 

are new or revised since the last inspection, scan them into eNSpect as an exhibit. 

This information will be reviewed by CFSAN/ONFL/Food Labeling and Standards 

Staff (HFS-820). 

c) Attachment A must be completed and sent electronically to the CFSAN Premarket 

Notification and Infant Formula Regulations Policy Contact (see Part VI) upon 

completion of the inspection when information obtained during the inspection 

indicates changes in processing or formulation have occurred. 

Report all domestic sample collections in the Field Accomplishment and Compliance 

Tracking System (FACTS). 

Report all import sample collections and field/label examinations in the appropriate import 

system. (See the Field Reporting Requirements section on page 2). 

Report domestic sample collections utilizing the following PAC/PAF Combinations: 

PAC PAC Description PAF PAF Description

21006 Infant Formula Survey NIF

MIC

Infant formula Survey Reporting

Microbiological Analysis 

21006N Domestic Infant Formula 

Environmental Samples 

MIC Microbiological Analysis

03040U Focused PCHF N/A N/A
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PART IV – ANALYTICAL

Analyzing Laboratories 

For nutrient analysis: 

ATLHAF Nutrient Analysis Branch (NAB) 

For microbiological analysis: 

ATLHAF/Microbiology Branch 

ARLHAF/Microbiology Branch

DENLHAF/Microbiology Branch 

NYLHAF/Microbiology Branch 

SEAHAF/Microbiology Branch

SANLHAF/Microbiology Branch 

IRVLHAF/Microbiology Branch 

Samples collected from the manufacturers that failed to meet premarket notification 

requirements are to be analyzed for microbiological analysis (Cronobacter spp. and 

Salmonella spp.) and abbreviated nutrition analysis testing (4 indicator nutrients). The lab 

should conduct comprehensive nutrient analysis if the results from the indictor nutrients 

analysis are negative.

Analyses to be Conducted

Nutrients and microbiological analyses

Methodology 

Sample composites shall be analyzed using a method from the FDA foods program compendium 

of analytical methods or an AOAC official method, as available and appropriate for infant 

formula, as shown below. These sources shall take precedence over single lab validated method. 

All methods must be validated for infant formula, and any method extensions must follow the 

FDA foods program guidelines for the validation of chemical methods and be completed prior to 

the submission of regulatory sample results. Any new nutrient analysis methods that are 

developed and validated must be agreed upon in advance by the Office of Regulatory AffairsOffice of Human and Animal Food Laboratory Operations (OHAFLO) and the CFSAN methods 

contacts (listed below). 

(a) Nutrient Analyses 

• Prepare a composite using the AOAC, Current Edition, Method 985.30. 

• Assay finished product infant formulas for all nutrients listed in 21 CFR Part 107, 

Subpart D except for choline, iodine, and inositol. 
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• Use factor 6.25 to convert nitrogen content to protein for meat/poultry, 5.71 for soy, 

or 6.38 for milk, as appropriate.

NOTE: The protein content can be calculated from the nitrogen present by applying a 

factor considered suitable for a particular food. Many commonly occurring proteins 

contain approximately 16% nitrogen and 6.25 is the factor often used for general purposes. 

Other more specific factors are available and must be used when appropriate. For 

example, the factor of 6.38 is appropriate for milk and the factor 5.71 is appropriate for 

soy protein. If there are any questions, contact CFSAN/ORS Methods Contacts (see Part VI).

Calculate carbohydrate by difference and kilocalories per unit weight or volume as appropriate. 

Use the determined kilocalories to calculate nutrient content per 100 kilocalories. 

Exempt infant formulas and other specially formulated formulas must be analyzed for all 

nutrients listed as absent for medical reasons (e.g., “lactose free”, analyze for lactose). 

Analyze the composite by the following methods or validated, equivalent techniques: 

Official Methods of Analyses (AOAC) International Current Edition

1. Biotin (Vitamin B7) AOAC 2016.02 or LIB 4523

2. Chloride AOAC 986. 26 or AOAC 2016.03

3. Cobalamin (Vitamin B12) AOAC 2011. 10 or AOAC 2014.02

4. Calcium, Copper, Iron, 

Magnesium, Manganese, 

Phosphorous, Potassium, 

Sodium, and Zinc

AOAC 2011.14 or AOAC 2015.06 or EAM4.4 or 

4.7** 

5. EFA (Linoleic Acid) Method AOAC 2012.13 or AOAC 996.01

6. Fat Method AOAC 2012.13 or AOAC 996.01

7. Folic Acid (Vitamin B9) AOAC 2004.05 or AOAC 2011.06

8. Niacin (Vitamin B3) AOAC 985. 34 or AOAC 2015.14 or WSV method

9. Pantothenic Acid (Vitamin B5) AOAC 2012. 16 or WSV method

10. Proximates (Protein, Ash, Method 986. 25 or AOAC 990.03 

11. Pyridoxine (Vitamin B6) AOAC 2004.07 or AOAC 2015.14 or WSV method

12. Riboflavin (Vitamin B2) AOAC 985. 31 or AOAC 2015.14 or WSV method

13. Sampling AOAC 985.30

14. Selenium Method 2011. 19 or 2015.06 **

15. Thiamin (Vitamin B1) AOAC 986. 27 or AOAC 2015.14 or WSV method

16. Vitamin A AOAC 992.06 or AOAC 2012.10 99992.032016.13

17. Vitamin C AOAC 985. 33 or AOAC 2012.22

18. Vitamin D AOAC 2016.05

19. Vitamin E AOAC 992.03 or AOAC 2012.10

20. Vitamin K AOAC 999.15 with modifications as needed for 

specific matrices* 
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*Note 1: AOAC Official Method 999.15 is not adequate to extract vitamin K from nutritional 

products formulated with free amino acids and partially hydrolyzed proteins. For such cases, 

the publication “Modifications of AOAC Official Method 999.15 to improve the quantitation 

of vitamin K1 in complex formulated nutritional products” [Schimpf et al., 2010 J. AOAC Int. 

93 (2): 650-662 and Delmonte et al., 2013, J. AOAC Int. 96 (1): 91-101] should be consulted 

and appropriate adjustments made. 

**Note 2: If using an AOAC method for elemental analysis, the inclusion of quality assurance 

measures included in Elemental Analysis Manual Methods (e.g., digestion blank, sample 

duplicate, reference material) is required. 

Calculate levels detected as follows:

• Convert amount of nutrient found by analysis to units per 100 kcal as listed in 

section 412 of the Act (i.e., calculate to respective nutrient units) 

• Convert amount of nutrient found by analysis to the respective nutrient units 

declared on the label

(b) Microbiological Analyses 

Salmonella

Refer to the BAM Chapter 5: Salmonella | FDA Current Edition. 

 

Perform the following analyses on each sample of soy or milk based finished products and soy 

or milk-based ingredients. 

NOTE: Before proceeding with the following microbiological analyses, prepare four

composites from the 60 subsamples for Salmonella analysis. 

Each composite must be prepared as follows: 

a) Using subs 1-15 remove 25 ml or g from each of 15 subsamples for a total of 375 ml 

or g for composite 1; then 

b) Using subs 16-30 remove 25 ml or g from each of 15 subsamples for a total of 375 ml 

or g for composite 2; then

c) Using subs 31-45 remove 25 ml or g from each of 15 subsamples for a total of 375 ml 

or g for composite 3; then 

d) Using subs 46-60 remove 25 ml or g from each of 15 subsamples for a total of 375 ml 

or g for composite 4; then 

e) Analyze each of the four 375 mL or g composites using the instructions below. 
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NOTE: The VIDAS Salmonella SLM as a screening method has been used by FDA field

labs in recent years for analysis of samples. 

(a) VIDAS Salmonella SLM (AOAC OMA method 2004.03) 

(b) VIDAS Salmonella SLM Easy (AOAC OMA method 2011.03) 

NOTE: FDA Salmonella qPCR assay as a screening method has been posted on the Foods 

Program Compendium of Analytical Laboratory Methods | FDA and validated for PIF. Any of 

the ORA field labs that correctly performed the FDA Salmonella qPCR MLV can use the 

qPCR method for the analysis of PIF. 

Isolation and Confirmatory Tests - BAM, Chapter 5 

NOTE: The serovar of Salmonella that has been identified in the contamination of some dried 

infant formula samples is S. Tennessee, a member of Salmonella Group C1. Recent isolates of 

this serovar from dried products have been lactose-positive, so please be aware that infant 

formula can be contaminated with lactose-positive Salmonella. 

Sample Preparation 

Combine 25 g (ml) from each of 15 individual sub-samples into a sterile flask (375 g (ml) 

composite), or other appropriate container. Add 3,375 ml lactose broth and mix thoroughly to 

a smooth suspension. Loosely cap the flask. Let stand for 60 ± 5 min. Adjust pH to 6.8 ± 0.2, 

if necessary. Four composites are prepared. Incubate composite at 35 ± 2o C for 24 ± 2 h. 

Testing

After pre-enrichment, samples are to be selectively enriched as described below.

a) For the Salmonella culture method, transfer 0.1 ml pre-enriched broth to 10 ml RV 

medium and 1 ml pre-enriched broth to 10 ml TT. Vortex. Incubate RV medium for 

24 ± 2 h at 42 ± 0.2°C and incubate TT broth 24 ± 2 h at 35 ± 2°C. Incubate both RV 

and TT in a circulating thermostatically controlled water bath. After incubation, 

follow the BAM Online, Salmonella, Chapter 5, section D, Isolation of Salmonella. 

 

b) For the VIDAS SLM Assay for Salmonella (AOAC OMA method 2004.03), transfer 

0.1 ml pre-enriched broth to 10 ml RV medium and transfer 1 ml pre-enriched broth 

to 10 ml TT broth and incubate in a circulating, thermostatically controlled water bath

for 6-8 h at 41-42°C. Subculture 1ml aliquots from the incubated TT and RV broths to

separate tubes containing 10 ml portions of M- broth (post enrichment) and incubate at

41-42°C for 18-24 h. Continue as described in the kits (AOAC OMA method 2004.03) 

instructions. 

c) For the VIDAS® Easy Method (OMA First Action Method 2011.03), transfer 0.1 

ml pre-enriched broth to 10 ml SX2 broth and incubate in a circulating,
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thermostatically controlled water bath for 18-24 h at 41-42°C. Continue as described

in the kits instructions (AOAC 2011.03). 

d) For the FDA Salmonella qPCR method, follow the protocol 

(https://www.fda.gov/media/168834/download) for sample collection from preenrichment culture (Section D) , DNA extraction (Section E) and qPCR analysis 

(Section F-H). Modified boiling DNA extraction method (E 2) and automatic DNA 

extraction methods (E 3) are recommended to use for infant formula. 

e) Presumptive positive samples must be confirmed culturally by streaking selective 

enrichments to selective agars as described in the BAM Online, Salmonella, Chapter 5, 

section D-3 and section D-4. Continue as described in the BAM. 

Positive Isolates:

Laboratories must perform whole genome sequencing (WGS) upon confirmation of Salmonella.

Cronobacter 

Refer to BAM Chapter 29 for analysis of finished product and raw ingredients. Refer to 

DFPG# 14-04: FY14 Inspection and Environmental Sampling of Milk Powder Facilities for 

 analysis of environmental samples. 

For finished product and raw ingredients that need alternative sample preparation and 

enrichment procedures, contact CFSAN ORS Methods Contacts for specific instructions. 

For finished product and raw ingredients, each composite must be prepared as follows: 

A) Using subs 1-10, remove 10 ml or grams from each of 10 subsamples for a total of 

100 ml or g for composite 1, then; 

B) Using subs 11-20, remove 10 ml or grams from each of 10 subsamples for a total 

of 100 ml or g for composite 2, then; 

C) Using subs 21-30, remove 10 ml or grams from each of 10 subsamples for a total 

of 100 ml or g for composite 3 

Analyze each of the 3 composites following BAM Chapter 29: Cronobacter. 

ORA laboratories will perform WGS on all Cronobacter spp. isolates recovered. 

Reporting

CFSAN and ORA contact information are provided in Part VI of this compliance program. 

ORA laboratories will inform ORS Scientific Program Coordinators (SPCs) to immediately 

contact CFSAN Regulatory/Compliance Contacts, the CFSAN Premarket Notification and 
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Infant Formula Regulations Policy Contact, CFSAN Compliance Program Contacts, ORA 

Critical Foods Coordination Team as well as the home OHAFO division when: 

• Sample results with the following microbiological values are found: 

Salmonella spp.: presence

Cronobacter spp.: presence 

• Nutrient levels are found below the minimum or above the maximum permitted in 

section 412(I) of the Act and 21 CFR 107.100. 

 Reporting of Results to CFSAN and the Home OHAFO Division 

ATLHAF/NAB should use the following criteria to determine when analytical results should 

be forwarded to the Compliance Branch of the home OHAFO division for further evaluation: 

• The amount of any nutrient in the product is less than the minimum level or greater 

than the maximum level specified for each 100 kilocalories of infant formula as 

defined in section 412(i) of the Act and 21 CFR 107.100. 

• The calorie, total fat, or sodium content exceeds the value declared on the label by 

20% or more. 

• For any added vitamin, mineral, protein, or linoleic acid, the nutrient content is not at 

least equal to the value declared on the label for that nutrient.

 

• An exempt infant formula that is found to contain a nutrient(s) which it is specifically 

formulated to not contain. 

Per FMD-147, ORA laboratories will communicate sample analytical findings to the 

appropriate compliance units and other FDA stakeholders identified in Part IV of the 

compliance program. 

• Preliminary and Final results will be communicated using the CRO/Final Result 

SharePoint Notification tool. 

• All final results will be entered into the Field Accomplishment and Compliance 

Tracking System (FACTS) and completed analytical worksheet packets will be 

uploaded to CMS as soon as possible following final result notification. 

• Per FMD-147 and the ORA Laboratory Manual, completed original analytical findings 

will be submitted electronically to the responsible party named in the Collection 

Remarks on the Collection Report in an FDA 1551 Form. 
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Data Reporting: 

Reporting PAC/PAF Combinations 

PAC PAC Description PAF PAF Description

21006 Infant Formula Survey NIF

MIC

Infant Formula Survey Reporting

Microbiological Analysis 

21006N Domestic Infant Formula 

Environmental Samples

MIC Microbiological Analysis
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PART V - REGULATORY/ADMINISTRATIVE STRATEGY

The overarching program goal is to ensure that infant formula is safe and meets 

manufacturing, nutrient, and labeling requirements. The goal of this regulatory strategy is to 

obtain high rates of industry compliance with requirements applicable to infant formula. As 

part of FDA’s enhanced oversight of infant formula, FDA’s regulatory strategy is focusing on 

taking appropriate, timely action to achieve compliance in an expeditious manner. These 

actions are intended to drive safety forward and advance the building of a more resilient, safe, and 

nutritious infant formula supply. 

 

OHAFO and OIO divisions may consider the following when considering an appropriate 

regulatory response related to infant formula: 

1. Situations Presenting a Health Hazard 

If a situation poses a possible health hazard, whether it pertains to conditions at a firm or 

analytical findings, the initial focus will be on the safety of the product and taking action to 

remove impacted product from the marketplace. If such conditions are identified, the 

OHAFO or OIO should contact the CFSAN/Regulatory Contacts immediately. CFSAN may 

support proceeding directly to a compliance action such as recall, seizure, injunction, or 

import regulatory action. 

 

If a review of records during an inspection of the firm’s microbiological testing of finished 

product and/or in-process product has detected Salmonella and/or Cronobacter that has not 

been notified to FDA, please notify CFSAN/Regulatory Contacts immediately of these 

findings. To further assess the firm’s evaluation of impacted products and subsequent 

corrective actions, we would recommend obtaining information surrounding this incident to 

include: 

 

• name of product(s) 

• product type (i.e.: liquid or powder) 

• volume of product produced 

• routine formula or exempt formula? 

• the organism detected

• identification of the manufacturing scheme

For example: 1) wet-mix/spray-dry or 

2) wet-mix/spray-dry/dry-blend or 

3) dry blend only 

• identification of the firm’s cleaning and sanitization activity that occurred before and 

after the lot with the positive finding(s) was produced 

• identification of the firm’s cleaning and sanitization activity which may have occurred 

during the production campaign 

• corrective actions the firm took in response to the product positive(s) 

• copy of the firm’s root cause analysis/investigation 
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• information on how the firm assessed other potentially impacted product within that 

campaign

• distribution information and/or current disposition of product(s) 

For example: is the product still within the firm’s control? If not, what volume of the 

product was distributed? 

Further evaluation of impacted products and subsequent corrective actions may result in the 

consideration of prompt compliance action, including recall. 

 

2. Domestic and Foreign Inspections

Compliance follow-up inspections: CFSAN requests communication with OHAFO prior to 

the initiation of a non-routine inspection to discuss strategy and requests updates during the 

inspection. These updates should include significant findings regarding the firm’s 

microbiological or nutrient testing of finished product and in-process product; significant 

findings regarding the firm’s environmental monitoring program; developing observations of 

concern to include routes of contamination; and/or findings related to consumer complaint 

follow up. CFSAN requests that these inspectional updates be sent to CFSAN/ Regulatory 

Contacts and Compliance Program Contacts listed in Part VI.

 

Factors to Consider 

The following factors should be considered when contemplating a compliance action: 

• Is the deficiency indicative of a problem which may lead to a route of contamination? 

Observations associated with potential routes of contamination are significant and 

would generally warrant a compliance response. 

• Is the deficiency an isolated (one-time) situation or a systemic issue?

An isolated issue (e.g., a piece of equipment dedicated to a low hygiene zone is used 

in a medium hygiene zone) may be of lesser concern, whereas a pattern of deviations 

(e.g., equipment is not dedicated to a specific hygiene zone, moves all over the 

facility without proper cleaning and sanitizing between zones) may be of greater 

significance. 

• Is the finding a first-time observation or repeat over multiple inspections? 

Repeat observations may be more significant because they may be indicative of a 

general lack of control and inability to make lasting corrections. 

• Has the facility been forthcoming with information regarding product positives, and 

taken appropriate corrective action? 

• If the facility had a recent recall related to food safety, is the observation associated 

with the root cause of the recall? 
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Observations associated with the root cause of a recall may be more significant 

because they may indicate a lack of process controls or may show the firm’s

inability to fully address product safety issues 

Observations of significant public health importance 

Observations of significant public health importance are those that have contributed to or have 

a high likelihood of contributing to product contamination or a failure of the infant formula to 

provide the necessary nutrients if not corrected. These observations are significant and should 

be included on a Form FDA 483, Inspectional Observations. An inspection of an infant 

formula facility that identifies these types of observation(s) will generally be classified as 

“Official Action Indicated” (OAI) and may require immediate action to address violative 

product and /or issuance of an advisory action. 

Based on review of conditions during recent inspections of infant formula manufacturers, 

critical findings resulting from evidence collected include: 

 

• Violative results from microbiological testing in finished product or in-processed

product samples 

 

• Violative results from nutrient testing:

o The amount of any nutrient in the product is outside of the specifications in 

section 412(i) of the Act and 21 CFR 107.100. 

o The analyzed caloric content, total fat, or sodium exceeds the value declared on 

the label by 20% or more. 

o For any added vitamin, mineral, protein, or linoleic acid, the nutrient content is 

not at least equal to the value declared on the label for that nutrient. 

o An exempt infant formula is determined by analysis to contain a nutrient(s) 

that it is specifically formulated to not contain. 

 

• Violative environmental findings for target pathogens (Salmonella and/or 

Cronobacter) with no appropriate corrective action.

• Inspectional observations which could contribute to routes of contamination including, 

but not limited to: 

o Lack of water control in dry production areas 

o Lack of appropriate corrective actions and conducting a root cause 

analysis/investigation following the isolation of a pathogen from an 

environmental sample or a product sample 

o Lack of appropriate hygienic zoning controls 

o Facility and/or equipment disrepair 

 

• Failure to conduct an appropriate investigation when information signals a potential 

problem, such as a consumer complaint. 

 
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If the inspectional observations encompass any of the above-mentioned areas of concern, prior 

to closing out an inspection please schedule a meeting with the CFSAN/Regulatory Contacts 

to further discuss. If inspectional or analytical findings warrant regulatory consideration, 

CFSAN would consider pursuing an action which may include, warning letter, seizure, or 

injunction. 

 

Other Observations 

 

Observations that do not fall within the examples above but that could impact the safety of the 

product or nutrient content if not corrected would normally be included on the Form FDA 

483. This would also include observations that could develop into a larger issue if the firm 

fails to address the problem or fails to monitor the adequacy of their corrective actions. 

Inspections with these types of observations may be classified as OAI and may result in a 

regulatory action, especially if the issues are repeated from previous inspections or are 

indicative of a systemic problem. 

 

Observations that are not likely to have an impact on the safety or nutrient content of the 

product will generally not be included on the Form FDA 483, unless they are repeat 

observations. Inspections with these types of observations will usually be classified as “No 

Action Indicated” (NAI) and the observations will be discussed with facility management. 

Although these observations are generally not considered significant from a public health 

perspective, facilities should be encouraged to address these observations during the 

inspection closeout. 

3. Imported Infant Formula 

Import divisions should submit a detention recommendation case within CMS to 

CFSAN/OC/DE/DSLAB (prior to issuing Notice of FDA Action) for infant formula when: 

• samples are positive (LC 2 or LC 3) for one or more microbiological analyte(s) of 

public health significance 

o The most common analytes are Salmonella and Cronobacter; however, other 

analytes may be found which support subsequent regulatory action.

o The CFSAN/Regulatory Contact should be alerted as soon as possible when 

positive microbiological sample results are identified.

 

• samples are violative for an abbreviated or comprehensive nutrient analysis (LC 2 or 

LC 3): 

o The amount of any nutrient in the product is outside of the specifications in 

section 412(i) of the Act and 21 CFR 107.100. 

o The analyzed calorie, total fat, or sodium content exceeds the value declared on 

the label by 20% or more. 

o For any added vitamin, mineral, protein, or linoleic acid, the nutrient content is

not at least equal to the value declared on the label for that nutrient. 
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o An exempt infant formula is determined by analysis to contain a nutrient(s) that it 

is specifically formulated to not contain.

• the product is misbranded in a significant way 

o Examples include: failure to declare an allergen; failure to bear required nutrient 

information; unauthorized nutrient content or health claims; failure to bear 

required information in English; failure to bear directions for use. 

Detention recommendations must be accompanied by all analytical worksheets and other 

appropriate documentation (entry paperwork, collection report, labeling, etc.). Division 

recommendation should include a request for evaluation for the placement of the firm and 

product on the applicable Import Alert. CFSAN will review the detention recommendation 

case concurrently for possible addition to detention without physical examination, as 

circumstances warrant. 

If concurrence for addition of a firm/product to DWPE has been provided by CFSAN within 

the detention recommendation case, import divisions should submit a recommendation to 

OIO/DIO to add the firm/product to DWPE under Import Alert #40-05, “Detention Without 

Physical Examination of Infant Formula Due to Failure to Meet Nutrient and Labeling 

Requirements,” (see import alert for applicable adulteration and misbranding charges) or other 

applicable Import Alert(s).

Further, screening criteria is a formal request to flag a specific firm and/or product 

combination to ensure coverage of future shipments to develop additional evidence to support 

an FDA action. Prior to requesting screening criteria, import divisions should consult with the 

CFSAN Regulatory/Compliance Contacts to ensure that holds, investigations, and sampling 

are appropriate for the specific firm/product combination. 

4. Charges 

Charges that may be applicable to this program include: 

• The product is adulterated within the meaning of section 412 of the Act [21 U.S.C. 

§ 350a] in that (1) such infant formula does not provide nutrients as required by 

subsection 412(i); (2) such infant formula does not meet the quality factor 

requirements prescribed by the Secretary under subsection 412(b)(1); or (3) the 

processing of such infant formula is not in compliance with the good manufacturing 

practices and the quality control procedures prescribed by the Secretary under 

subsection 412(b)(2). 

• An article of food is adulterated under section 402(a)(4) of the Act [21 U.S.C. 

§ 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions 

whereby it may have become contaminated with filth, or whereby it may have been 

rendered injurious to health. 
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• An article is misbranded within the meaning of section 403(a)(1)/201(z) of the Act [21 

U.S.C. §§ 343(a)(1)/321(z)] in that the label is false or misleading because the product 

purports to be an infant formula intended to be used as the sole source of nutrition by 

infants less than 12 months old; however, the product is not labeled as required by 21 

CFR Part 107. 

• The failure to provide the notice required by section 412(c) [21 U.S.C. § 350a(c)] or 

412(e) [21 U.S.C. § 350a(e)], the failure to make the reports required by section 

412(f)(1)(B) [21 U.S.C. § 350a(f)(1)(B)], the failure to retain the records required by 

section 412(b)(4) [21 U.S.C. § 350a(b)(4)], or to fail to meet the requirements 

prescribed under section 412(f)(3) [21 U.S.C. § 350a(f)(3)] are prohibited under 

section 301(s) of the FD&C Act [21 U.S.C. § 331(s)]. 

• The failure of the owner, operator, or agent in charge of a covered facility to comply 

with the preventive control provisions of the Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation 

(CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 is prohibited by 

section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)]. 

Examples of situations where a preventive controls citation might be used include 

issues with conducting and having a written hazard analysis (21 CFR 117.130) or 

establishing and implementing an adequate supply-chain program (21 CFR Part 117, 

Subpart G). 

5. Requirements Related to Recalls

• Under new 412(k) of the FD&C Act, FDA is required to notify Congress within 24 

hours after the initiation of an infant formula recall. The recall notification must 

include specific information related to the recall and an estimate of the disruption in 

the marketplace.

• Section 3401(h) of the Food and Drug Omnibus Reform Act of 2022 requires that after 

initiation of a recall, manufacturers submit a plan to FDA of the actions the 

manufacturer will take, including to identify and address the root cause and restore 

operation of the impacted facilities (this section sunsets September 30, 2026). 

• Section 3401(i) of the Food and Drug Omnibus Reform Act of 2022 requires certain 

types of communication with the manufacturer after an inspection of a facility 

impacted by a recall. When conducting an inspection under circumstances covered 

under this section of the Food and Drug Omnibus Reform Act of 2022, consult with 

the CFSAN/Regulatory Contact before initiation and close out of the inspection. 
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PART VI REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS

References 

Guide to Inspections of Manufacturers of Miscellaneous Food Products, Volume II, Section 4. 

(http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074988.htm) 

Federal Food Drug & Cosmetic Action, Section 412 (21 U.S.C 350a)

Code of Federal Regulations, Title 21, Part 106, “INFANT FORMULA REQUIREMENTS 

PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 

PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS” 

eCFR :: 21 CFR Part 106 -- Infant Formula Requirements Pertaining to Current Good 

Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and 

Notifications

Code of Federal Regulations, Title 21, Part 107, “INFANT FORMULA” (including Subpart E - 

Infant Formula Recalls). 

eCFR :: 21 CFR Part 107 -- Infant Formula

Code of Federal Regulations, Title 21, Part 108, “EMERGENCY PERMIT CONTROL”

eCFR :: 21 CFR Part 108 -- Emergency Permit Control

Code of Federal Regulations, Title 21, Part 113, “THERMALLY PROCESSED LOW-ACID 

FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS”

eCFR :: 21 CFR Part 113 -- Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed 

Containers

Code of Federal Regulations, Title 21, Part 114, “ACIDIFIED FOODS”

eCFR :: 21 CFR Part 114 -- Acidified Foods

Code of Federal Regulations, Title 21, Part 117, “GOOD MANUFACTURING PRACTICE, 

HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD”

eCFR :: 21 CFR Part 117 -- Current Good Manufacturing Practice, Hazard Analysis, and Risk–

Based Preventive Controls for Human Food

Link to Exempt Infant Formulas Marketed in the United States By Manufacturer and Category 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Infant

Formula/ucm106456.htm

Link to Infant Formula Regulation Update training course ORA LearnED Training System
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Attachments 

(See Infant Formula Resource Page) 

A. Reporting Changes in Processing and Reformulation for Infant Formulas 

B. Infant Formula Nutrient Information Reporting Form

C. Foreign Infant Formula Manufacturers and Products

D. Domestic Infant Formula Manufacturers and Products 

Program Contacts 

(See “Infant Formula Program Contacts Information” in the Infant Formula Resource Page). 

Compliance Program Contacts 

Kaniz Shireen, CFSAN/OC/DFPG/Program Assignment Monitoring Branch, 

Phone: 240-402-2775, Kaniz.Shireen@fda.hhs.gov 

Janice King, CFSAN/OC/DFPG/Program Assignment Monitoring Branch, 

Phone: 301-796-3454, Janice.King@fda.hhs.gov 

CFSAN Regulatory/Compliance Contact

Marjorie Davis, CFSAN/OC/DE/Dietary Supplement and Labeling Compliance Branch 

(DSLAB), 

Phone: 240-402-6672, Marjorie.Davis@fda.hhs.gov

 

Asha Dwarka, CFSAN/OC/DE/ Food Adulteration and Assessment Branch (FAAB), 

Phone: 240-402-5164, Asha.Dwarka@fda.hhs.gov

CFSAN Premarket Notification and Infant Formula Regulations Policy Contact

Carrie Assar, CFSAN/ONFL/Infant Formula and Medical Foods Staff (IFMFS), 

Phone: 240-402-1453, Carrie.Assar@fda.hhs.gov

CFSAN Office of Regulatory Science (ORS) Method Contacts

Microbiological Analysis 

Yi Chen, CFSAN/ORS/DM, HFS-710, 

Phone: 240-402-2783, Yi.Chen@fda.hhs.gov 

Rachel Binet, CFSAN/ORS/DM, HFS-711, 

Phone: 240-402-2468, Rachel.Binet@fda.hhs.gov 
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Nutrients, Metals Analysis 

Shaun MacMahon, CFSAN/ORS/DBC, HFS-706, 

Phone: 240-402-1998, Shaun.MacMahon@fda.hhs.gov 

Christine Parker, CFSAN/ORS/DBC, HFS-7070, 

Phone: 240-402-2019, Christine.Parker@fda.hhs.gov 

Patrick Gray, CFSAN/ORS/DBC, HFS-716, 

Phone: 240-402-5026, Patrick.Gray@fda.hhs.gov 

ORA/Office of Human and Animal Food Laboratory Operations (OHAFLO) Methods 

Contacts

Microbiological Analysis 

ORS Scientific Program Coordinators (SPCs) 

Microbiological Analysis (oraorsoffloiomicro@fda.hhs.gov) 

Jeremi Mullins, ORA/Office of Human and Animal Food Laboratory Operations, 

Phone: 404-575-1582, Jeremi.Mullins@fda.hhs.gov

Julia Manetas, ORA/Office of Human and Animal Food Laboratory Operations, 

Phone: 718-340-7034 x7034, Julia.Manetas@fda.hhs.gov

Jennifer Kinney, ORA/ORS OHAFLO Microbiology Staff Director 

303-236-3107, jennifer.kinney@fda.hhs.gov 

Nutritional Analysis

Yanxuan (Tina) Cai, ORA/Office of Human and Animal Food Laboratory Operations, Human 

and Animal Food Scientific Staff- Chem, 

Phone: 240-402-1369, Yanxuan.Cai@fda.hhs.gov

Aubrey Shahriari, ORA/Office of Human and Animal Food Laboratory Operations, 

ATLHAF/NAB, Phone: 404-253-2345, Aubrey.Shariari@fda.hhs.gov

Nutrients, Metals Analysis

Michael Wichman, ORA/Office of Human and Animal Food Laboratory Operations, Human 

and Animal Food Scientific Staff- Chem, 

Phone: 240-705-1786, Michael.Wichman@fda.hhs.gov

ORA Inspectional Inquiries 

Elizabeth Mayer, ORA/OHAFO, HFR-CE850, 

Phone: 612-834-4830 (cell), Elizabeth.Mayer@fda.hhs.gov
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Andrea Charles-Julien, ORA/OHAFO/, HFR-SE2560, 

Phone: 561-416-1065 x 1110 (Office), Andrea.Charles@fda.hhs.gov 

CFSAN Import Contact 

Bobby Hatch, CFSAN/OC/DE, HFS-607, 

Phone: 240-402-6081, Robert.Hatch@fda.hhs.gov, 

ORA Office of Import Operations (OIO) Contacts

DIO CFSAN Liaisons ORA OIO DIO CFSAN Liaisons 

(ORAOEIODIOCFSANLiaisons@fda.hhs.gov) 

Allison Scott, ORA/OIO/DIO/IOB

Phone: 301-796-4526, Allison.Scott@fda.hhs.gov
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PART VII - CENTER RESPONSIBILITIES

The Office of Nutrition and Food Labeling (ONFL) and Office of Food Safety (OFS) will provide 

subject matter expertise in the maintenance and evaluation of the compliance program and 

provide guidance to the Office of Compliance with regard to program priorities, relevant 

evaluation questions, and recommended program changes. The Office of Compliance will lead 

the effort and work in conjunction with ONFL to prepare routine compliance program 

evaluations. Evaluation will be conducted on a periodic basis and outline the program office’s 

current objectives, general and specific program evaluation questions, list recommendations for 

process improvement, and highlight data patterns and trends for better targeting and resource 

allocation. The Office of Compliance will make these evaluations available internally to FDA. In 

addition, the Office of Compliance will prepare an annual summary report of this compliance 

program which will be available for internal use only at Compliance Program Summaries.
FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM MANUAL PROGRAM 73000.000

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ATTACHMENT A 

Reporting Changes in Processing and Formulation for Infant Formulas 

Complete this form and send electronically to carrie.assar@fda.hhs.gov upon completion of the 

inspection. The information should be submitted whether or not the firm has previously reported 

the change to the Agency because many firms report insufficient data for the Agency to determine 

the significance of the change.

FIRM NAME ____________________________________________________ 

FIRM ADDRESS _________________________________________________ 

1. Nature of the change: Processing Formulation _______ Packaging_________ 

2. Has the company reported the change to FDA in accordance with 21 CFR 106.120(a), (b) and (c)? 

 Yes____ No ____. If yes, report the date the company reported the change: 

 

3. Name of the infant formula and forms (i.e. liquid, powder, concentrate) involved in the change: 

 

4. Describe the change in detail:

 

 
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5. Describe purpose(s) or reason(s) for the change: 

 

 

6. List nutrients changed (if any) and the target levels in the final product before and after 

reformulation: 

 

 

7. Describe equipment, processing, and packaging changes (if any) and their purpose: 

 

 

 

 
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8. Describe all testing completed or underway (chemical and biological) to assure compliance with 

nutrient requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act (the Act) and 

21 CFR 107.100 or any other nutrient added by the manufacturer. 

9. Describe all testing completed or underway to assess nutrient bioavailability in the final product 

to assure compliance with section 412(a)(2) (specific testing required by 21 CFR 106.96(b) and 

(f) or exemptions as provided for under sections 106.96(c) and (g) for non-eligible infant formulas 

and the records required under 106.96(i) for eligible infant formulas): 

 

 

10. Has the firm submitted the verification notification required under 106.130? 

 

 

11. Attach new labels if change resulted in any label changes. (attach additional sheet(s) if necessary) 
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ATTACHMENT B 

Infant Formula Nutrient Information Reporting Form 

This form is to be completed during each inspection of a finished product manufacturing process. It is 

intended to show the source of nutrients, at what stage of the manufacturing process they are analyzed, and 

the analytical methods used. Indicate the source of the nutrient using the abbreviations at the end of the 

form, on page 2, of this Attachment. Indicate the stage of the process by placing an "X" in the appropriate 

box. Indicate the method reference by giving specific number (e.g., AOAC #), or by general description 

(ICP, GC, etc.). Send the completed form along with the Summary of Findings to CFSAN and OHAFO. 

PRODUCT:_____________________________ 

FIRM NAME:___________________________ 

FIRM ADDRESS:__________________________________________ 

FEI:_____________ 

FORM OF PRODUCT (READY TO USE, POWDER, CONCENTRATE):_______________________ 

DATE:___________ 

Nutrient Source* Raw Material In Process Finished 

Product 

Method Reference

Protein

Linoleic Acid

Fat

Carbohydrate

Vitamin A
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Nutrient Source* Raw Material In Process Finished 

Product 

Method Reference

Thiamine (Vitamin B1)

Riboflavin (Vitamin 

B2)

Niacin (Vitamin B3)

Vitamin B6

Vitamin B12 

Folic Acid

Pantothenic Acid

Biotin

Vitamin C

Vitamin D

Vitamin E

Vitamin K

Choline

Inositol

Calcium
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Nutrient Source* Raw Material In Process Finished 

Product 

Method Reference

Phosphorus

Magnesium

Iron

Iodine

Zinc

Copper

Manganese

Sodium

Potassium

Chloride

Selenium

Other

*FSPM - Fat Soluble Premix, WSPM - Water Soluble Premix

MPM - Mineral Premix IA - Independent Addition, FB - Formula Base 
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ATTACHMENT C 

Infant Formula Products Manufactured by Foreign Manufacturers

Attachment C has updated list of foreign infant formula manufacturers, posted on Office of Compliance 

SharePoint site. 
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ATTACHMENT D

Infant Formula Products Manufactured by Domestic Manufacturers

Attachment D has updated list of domestic infant formula manufacturers, posted on Office of Compliance 

SharePoint site.