INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 7

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CHAPTER 7 - RECALL ACTIVITIES

CHAPTER 7 - RECALL ACTIVITIES ....................................... 7-1

SUBCHAPTER 7.1 - RECALLS ............................................ 7-1

7.1.1 - DEFINITIONS ............................................................ 7-1

7.1.1.1 - Recall...................................................................... 7-1

7.1.1.2 - Recall Classification................................................ 7-1

7.1.1.2.1 - CLASS I RECALL ................................................ 7-1

7.1.1.2.2 - CLASS II RECALL ............................................... 7-1

7.1.1.2.3 - CLASS III RECALL .............................................. 7-1

7.1.1.3 - Recall Type............................................................. 7-1

7.1.1.4 - Recall Strategy........................................................ 7-1

7.1.1.5 - Depth of Recall ....................................................... 7-2

7.1.1.6 - Recall Number ........................................................ 7-2

7.1.1.7 - Medical Device Notification Order........................... 7-2

7.1.1.8 - Medical Device Notification..................................... 7-2

7.1.1.9 - Medical Device Safety Alert .................................... 7-2

7.1.1.10 Sub-Recall............................................................... 7-2

7.1.1.11 Consignee............................................................... 7-2

7.1.1.12 Account ................................................................... 7-2

7.1.1.13 Division Recall Coordinator..................................... 7-2

7.1.1.14 Market Withdrawal .................................................. 7-2

7.1.1.15 – Notification, Non-distribution, and Recall of 

Controlled Substances for Human or Animal Use Order....... 7-2

SUBCHAPTER 7.2 - RECALL NOTIFICATION / INSPECTION

.............................................................................................. 7-3

7.2.1 - RECALL SCENARIOS ENCOUNTERED DURING 

INSPECTIONS...................................................................... 7-3

7.2.1.1 – Firm Has Used Recalled Product to Manufacture New 

Product.................................................................................. 7-3

7.2.1.1.1 – Potential New Food Recalls ................................ 7-3

7.2.2 – ROOT CAUSE INSPECTIONS ................................. 7-4

7.2.2.1 - State Monitored Recalls.......................................... 7-4

7.2.3 - MEDICAL DEVICE RECALLS ................................... 7-4

7.2.3.1 - Problem Identification.............................................. 7-5

7.2.3.2 - Corrective Action..................................................... 7-5

7.2.3.3 - Complaint and Medical Device Reporting (MDR) 

Reporting .............................................................................. 7-6

7.2.4 - DRUG RECALLS....................................................... 7-6

7.2.4.1 - Recalls of Human Drug Products............................ 7-6

7.2.4.2 - Recalls of Veterinary Drug Products ....................... 7-6

7.2.5 - HUMAN CELLS, TISSUES, AND CELLULAR AND 

TISSUE BASED PRODUCTS (HCT/Ps) FOR IMPLANTATION, 

TRANS-PLANTATION, INFUSION, OR TRANSFER ............ 7-6

7.2.6 – TOBACCO PRODUCT RECALLS ............................ 7-6

7.2.7 - SAMPLE COLLECTION............................................. 7-6

SUBCHAPTER 7.3 - MONITORING RECALLS.................... 7-7

7.3.1 - INSPECTIONS TO MONITOR RECALL PROGRESS . 7-

7

7.3.2 - FDA RECALL AUDIT CHECKS ................................. 7-7

7.3.2.1 - Definition................................................................. 7-7

7.3.2.2 - Level of Audit Checks ............................................. 7-7

7.3.2.3 - Conducting a Recall Audit Check............................ 7-7

7.3.2.4 - Audit Check Reporting ............................................ 7-8

7.3.2.5 - Ineffective Recalls................................................... 7-8

7.3.2.6 Endorsing the Recall Audit Check............................. 7-9

7.3.3 - RECALL TERMINATED/RECALL COMPLETED ....... 7-9

7.3.3.1 - Definitions ............................................................... 7-9

7.3.3.2 - Closeout Inspection ................................................ 7-9

SUBCHAPTER 7.4 - SPECIAL RECALL SITUATIONS........ 7-9

7.4.1 - General ...................................................................... 7-9

7-1 RECALL COMMUNICATIONS EXAMPLE.................... 7-11

7-2 FORM FDA 3177 RECALL AUDIT CHECK REPORT .. 7-14

..................................................................................... 7-14

7-3 Instructions for Completing the FDA 3177 Recall Audit 

Check Report ...................................................................... 7-15

SUBCHAPTER 7.1 - RECALLS

7.1.1 - DEFINITIONS

7.1.1.1 - Recall

A recall is a firm's removal or correction of a marketed 

product that the FDA considers to be in violation of the laws 

it administers and against which it would initiate legal action 

(e.g., seizure). Market withdrawals and stock recoveries are 

not considered recalls. See the FDA’s recall policy outlined 

in 21 CFR 7.1/7.59- Enforcement Policy - General 

Provisions, Recalls (Including Product Corrections) - 

Guidance on Policy, Procedures and Industry 

Responsibilities.

7.1.1.2 - Recall Classification

Recall Classification is the numerical designation, i.e., I, II, 

or III, assigned by the FDA to a particular product recall to 

indicate the relative degree of health hazard presented by 

the product being recalled.

7.1.1.2.1 - CLASS I RECALL

Class I Recall is a situation in which there is a reasonable 

probability that the use of, or exposure to, a violative 

product will cause serious adverse health consequences or 

death.

7.1.1.2.2 - CLASS II RECALL

Class II Recall is a situation in which use of, or exposure to, 

a violative product may cause temporary or medically 

reversible adverse health consequences or where the 

probability of serious adverse health consequences is 

remote.

7.1.1.2.3 - CLASS III RECALL

Class III Recall is a situation in which use of, or exposure 

to, a violative product is not likely to cause adverse health 

consequences.

7.1.1.3 - Recall Type

Recall type is a designation based on whether the recall is 

Voluntary, FDA Requested (at the request of the 

Commissioner or his/her designee), or ordered under 

section 518(e) of the FD & C Act [21 U.S.C 360h (e)].

7.1.1.4 - Recall Strategy

Recall strategy is a planned specific course of action to be 

taken in conducting a specific recall, which addresses the 
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depth of recall, need for public warnings, and extent of 

effectiveness checks for the recall.

7.1.1.5 - Depth of Recall

Depending on the product's degree of hazard and extent of 

distribution, the recall strategy will specify the level in the 

distribution chain to which the recall is to extend, i.e., 

wholesaler, retailer, user/consumer, which is known as the 

depth of recall. 

7.1.1.6 - Recall Number

The recall number is assigned by the responsible Center, 

for each recalled product it classifies. This number 

comprises a letter designating the responsible Center (see 

letter Codes below), a 3- or 4- digit sequential number 

indicating the number of recalls classified by that Center

during the fiscal year, and a 4-digit number indicating the 

fiscal year the recall was classified. For example: F-100-

2011 identifies the 100th recall classified by the Center for 

Food Safety and Applied Nutrition (CFSAN) in FY-2011. 

The following letters are used to identify the Centers.

Letter Center/Office

F Foods and Cosmetics - (CFSAN)

D Drugs - (CDER)

Z Medical Devices & Radiological Health – (CDRH)

V Veterinary Medicine and animal food/feed - (CVM)

B Biologics - (CBER)

N Medical Devices (Voluntary Safety Alerts and

Notifications)

T Tobacco Products – (CTP)

7.1.1.7 - Medical Device Notification Order

A medical device notification order is an order issued by 

FDA requiring notification under section 518(a) of the 

FD&C Act [21 U.S.C. 360h (a)]. The directive issues when 

FDA determines a device in commercial distribution, and 

intended for human use, presents an unreasonable risk of 

substantial harm to the public health. The notification is 

necessary to eliminate such risk when a more practicable 

means is not available under the provisions of the Act. 

7.1.1.8 - Medical Device Notification

A medical device notification is a communication issued by 

the manufacturer, distributor, or other responsible person in 

compliance with a Notification Order. It notifies health 

professionals, and other appropriate persons, of an 

unreasonable risk of substantial harm to the public health 

presented by a device in commercial distribution.

NOTE: Medical Device Notifications are to be handled by 

the divisions as recalls. They will go through the stages of 

alert, recommendation, classification, field notification, firm 

notification letter, firm effectiveness checks and status 

reports, FDA audit checks and termination 

recommendations.

7.1.1.9 - Medical Device Safety Alert

A medical device safety alert is a notification to device 

users that, under certain circumstances, use of or 

exposure to the device may pose a risk of harm (the 

exposure mentioned in this definition excludes electronic 

product radiation exposure - see 21 CFR Subchapter J). 

CDRH will only consider a notification to be a safety alert if 

the device is not violative. The notification alerts users of 

the associated risk and steps to be taken to reduce or 

eliminate the risk. Safety alerts will be entered in RES 

and processed accordingly. 

7.1.1.10 Sub-Recall

A sub-recall is an action taken by a recalling firm’s account 

to notify own-accounts/consignees of the recall where no 

changes were made to the recalled product.

If the recalling firm’s account changes the recalled product 

( e.g. used the product as a component of a new product, 

re-labeled the product to obscure the original product name 

and/or lot code, repackaged the product, etc.) the account 

will have created a new product which could warrant a new 

recall instead of a sub-recall.

7.1.1.11 Consignee

A consignee is anyone who received, purchased, or used 

the product being recalled.

7.1.1.12 Account 

The account is the location where the audit check is being 

done. 

7.1.1.13 Division Recall Coordinator 

Each Division has at least one Division Recall Coordinator 

who enters and monitors recalls. A list of Division Recall 

Coordinators and their contact information is at 

https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm

129334.htm

7.1.1.14 Market Withdrawal

A market withdrawal is a firm’s removal or correction of a 

distributed product for a minor violation that would not be 

subject to legal action by the FDA or that involves no 

violation (e.g., normal stock rotation practices, routine 

equipment adjustments, repairs, theft, etc.).

7.1.1.15 – Notification, Non-distribution, and 

Recall of Controlled Substances for Human 

or Animal Use Order 
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A controlled substance notification order is an order 

issued by FDA requiring non-distribution and the 

mandatory recall of controlled substances under section 

569D of the Act [21 U.S.C. 360bbb-8d], as amended by 

section 3012 of the Substance Use-Disorder Prevention 

That Promotes Opioid Recovery and Treatment for 

Patients and Communities Act (SUPPORT ACT). Refer to 

Chapter 7 of the REGULATOY PROCEDURES MANUAL 

, 7-5-3 FDA Mandated Controlled and Ordered Recalls 

and Attachment K.

SUBCHAPTER 7.2 - RECALL NOTIFICATION / 

INSPECTION

7.2.1 - RECALL SCENARIOS ENCOUNTERED 

DURING INSPECTIONS

The Division Recall Coordinator (DRC) or designee sends 

a recall alert within one working day of receiving necessary 

information to the appropriate Center Recall Unit (CRU) 

and OSPOP/DE/ROB (Office of Strategic Planning and 

Operational Policy Division of Enforcement Recall 

Operations Branch) through the Recall Enterprise System 

(RES) with basic information regarding the recall. See RPM 

Chapter 7-10, Attachment A for a list of information for the 

recall alert. 

A recommendation for recall classification is submitted 

through RES by the DRC or designee within five working 

days after the recalling firm has provided the information 

(10 days if the recall has already been completed). See 

RPM Chapter 7-10, Attachment B for a list of information 

for the recall recommendation. 

Due to the potential public health impact of recalls, when 

you find a recall during your inspection it is imperative to 

submit any information obtained to your DRC as soon as 

possible. The Division should not wait for writing, typing and 

submission of the EIR or memorandum when sharing recall 

documents with the DRC or submitting the recall alert or 

recommendation.

If the firm has decided to initiate a recall during an 

inspection or investigation, you should prioritize the 

removal of potentially hazardous product. Coordinate with 

your DRC and SCSO to ensure the following tasks are 

completed: 

1. Provide firm management with your DRC’s contact 

information and request that management obtain 

their FDA Division's review of recall 

correspondence and any press releases before 

they are issued to prevent misunderstandings 

between the firm, its customers, and the FDA. An 

updated list of contact information for FDA’s DRCs 

can be found at 

https://www.fda.gov/safety/industry-guidancerecalls/ora-recall-coordinators; 

2. At the firm’s request, provide guidance in preparing 

recall communications and obtain complete copies 

including the text of phone conversations to submit 

to your DRC. See Chapter 7 of the RPM, Industry 

Guidance for Recalls, and IOM Exhibit 7-1 for an 

example of recall communications; 

3. Obtain a complete distribution list of all shipments 

of the lot(s) involved, including foreign distribution; 

4. Obtain copies of all labels and labeling associated 

with the recalled product(s) and any documentation 

of what led to the recall; 

5. Advise the firm on how the returned products 

should be handled. Sometimes FDA will witness or 

otherwise verify the reconditioning or destruction of 

the products returned under the recall;

6. Obtain an Official Sample of the recalled product 

when necessary (See IOM 7.2.7); 

7. Obtain as much information in the RPM Chapter 7, 

Attachment B as time allows; and

8. Take any other steps necessary in your judgment, 

or that your Division requires. 

7.2.1.1 – Firm Has Used Recalled Product to 

Manufacture New Product

If you are conducting an inspection or investigation at a firm 

who has received recalled product and used it in the 

production of a new product, or has relabeled recalled 

product, it may warrant the initiation of a new recall. Collect 

documentation on how the recalled product was 

manipulated, including finished product labels, to provide to 

your DRC immediately. If there is question about the 

potential hazard or violation of the new product, discuss the 

situation with your DRC and SCSO prior to discussing the 

initiation of a new recall with the firm. 

7.2.1.1.1 – Potential New Food Recalls

For potential new food recalls, the following are some areas 

to be covered:

1. Incoming ingredient quality control procedures;

2. Quality control over ingredients at the time of use, and 

the products in which the ingredients are used;

3. A detailed description of the methods used in 

preparation and packaging of the processed product;

4. How the finished product is stored and shipped;

5. Labeling of product, and any cooking instructions for 

consumer or purchaser;

6. Quality control testing of the finished product. Detail any 

test(s) performed by firm; and

7. For products produced in USDA plants, determine if the 

USDA was notified of the suspect incoming ingredient? 

Did USDA determine what testing was done by the firm?

7.2.1.2 – Learning of Completed Recalls During Your 

Inspection

If you are conducting an inspection and learn that a recall 

has occurred, obtain the following from the firm to provide 

to your DRC:
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1. Complete copies of recall communications 

including the text of phone conversations;

2. Complete distribution list of all shipments of the 

recalled lot(s), including foreign distribution;

3. Specimens or copies of all labels and labeling 

associated with the recalled product(s); and

4. Take any other steps necessary in your judgment, 

or that your division requires. 

This information should be shared immediately. Do not wait 

until the submission of the EIR to notify the DRC that a 

recall has taken place.

7.2.2 – ROOT CAUSE INSPECTIONS 

If FDA learns of a potentially violative product that may 

cause or has caused a class I or significant class II recall, 

an inspection may be assigned to determine the root 

cause(s) of the problem(s). Deficiencies in the firm’s 

corrective and preventive action should be documented as 

violations subject to possible regulatory action. 

An important objective of the inspection is to identify the 

root cause for the recall and assure the firm has 

implemented effective corrective actions to eliminate its 

recurrence. In some cases, firm management will have 

conducted its own analysis and reached conclusions about 

the problem and its root cause. It is important to verify that 

the firm’s conclusions and judgments, about the root cause 

of the problem that led to the recall, are discriminating 

enough to identify the true cause(s) and steps taken are 

sufficient in depth and scope. Without identifying the true 

root cause, it will be difficult for the firm to implement an 

effective corrective action. 

Determine if the firm conducted a failure analysis using 

quality tools such as cause-and-effect diagrams (i.e.,

fishbone diagram or Ishikawa diagram), fault tree analysis 

(FTA), or failure mode and effects analysis (FMEA). 

Determine if the following variables were considered; 1) the 

length of time since the product had been manufactured 

and sold; 2) complaints or returns for the same or similar 

problems; 3) reworking of the product prior to release or 

distribution that may have been due to the same or similar 

problems; and 4) process or personnel changes which 

occurred about the time the problem appeared. 

In addition to verifying the identification of the root cause: 

1. Issue a Notice of Inspection (FDA 482); 

2. Discuss the suspected problem with 

management and review the firm's complaint 

file; 

3. Investigate all areas, control points and/or 

circumstances which may have a bearing on 

the product's deficiency; 

4. Fully develop individual responsibility for the 

problem; 

5. Review batch records, processing logs and/or 

other types of records for violative lots and 

associated lots; 

6. Review and obtain copies of the firm's quality 

control/analytical data; and

7. Determine any actions the firm has taken, is 

taking, or has planned to take to prevent similar 

occurrences. If corrective action is not 

underway, determine the firm's timetable for 

achieving correction.

7.2.2.1 - State Monitored Recalls

The FDA is not ordinarily involved in classifying and 

auditing Interstate Milk Shippers (IMS) and Interstate 

Shellfish Shippers (ISS) product recalls where such actions 

have been, or are being, handled expeditiously and 

appropriately by the State(s). However, the FDA Division

office in which the recalling firm is located must be assured 

that all States involved in an IMS or ISS plant's recall are 

participating in ensuring removal of the product from 

commerce and that, when appropriate, the States issue 

warnings to protect the public health.

In the event that the FDA determines that the States are 

unable to effect the recall actions necessary, it will classify, 

publish, and audit the recall; it will issue a public warning 

when indicated.

7.2.3 - MEDICAL DEVICE RECALLS

Medical device recalls may result from manufacturing 

defects, labeling deficiencies, failure to meet premarketing 

requirements [PMA, 510(k)], packaging defects or other 

nonconformance problems. How firms identify the causes 

of medical device recalls and corrective action activities is 

essential to the analysis of medical device failures and the 

determination of the effectiveness of the medical device 

GMP program. It is also useful in evaluating the medical 

device program, and for directing attention to problem 

areas during inspections. 21 CFR Part 806.1 requires 

device manufacturers and importers to report certain 

actions concerning device corrections and removals. They 

must also maintain records of all corrections and removals 

regardless of whether such corrections and removals are 

required to be reported to FDA. (See 21 CFR Part 806.20). 

Failure to report as required by 21 CFR 806.10 and failure 

to maintain records as required by 21 CFR 806.20 are 

violations and should be listed on the FDA483, Inspectional

Observations. You should collect documentation that will 

enable CDRH to evaluate the firm’s compliance with 21 

CFR Part 806. 

Each device manufacturer or importer must submit a written 

report to FDA of any correction or removal of a device 

initiated by such manufacturer or importer, if one was 

initiated:

1. To reduce a risk to health posed by the device; or

2. To remedy a violation of the Act caused by the device 

which may present a risk to health, unless the 

information has been provided according to 21 CFR 

806.10 (f), or the correction or removal action is exempt 
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from the reporting requirements under 21 CFR 

806.10(b).

Manufacturers of radiation-emitting electronic products 

which are also medical devices are subject to both the 

EPRC and Medical Device authorities of the FD&C Act. 

Manufacturers are required to perform corrective actions on 

their electronic products when a radiation safety problem 

exists involving a defect or a failure to comply with a 

mandatory performance standard. The corrective action is 

required to be a repair, replacement, or refund of such 

product at no cost to the consignee.

Collection of complaint, PMA and 510(k) related information 

is necessary to determine compliance with the GMP 

requirements. During recall follow-up inspections, answers 

should be obtained to the questions below, in addition to 

routine recall information. For firms where it has been 

established a manufacturing defect led to the recall, 

conduct a complete GMP evaluation of the manufacturing 

operations. Report such inspections into FACTS as 

"qualifying" GMP inspections.

7.2.3.1 - Problem Identification

1. How did the firm identify the nonconformance which led 

to the recall (e.g., complaint, in-house data, etc.)? 

2. If the recall was due to a device defect, did the firm 

conduct a documented failure analysis of the device, 

using such techniques as fault tree or failure mode 

analyses? If so, report whether these results were 

provided for review.

a. Did the firm determine the failure mechanism (e.g., 

shorted component, incomplete weld, etc.)? 

b. If not, how did firm determine the cause of the 

nonconformance?

c. If not, what rationale does the firm have for not 

conducting a failure analysis?

3. Did the firm determine at what phase of the device life 

cycle the nonconformance occurred (i.e., design, 

manufacturing, storage, use, etc.) and the actual cause 

of the nonconformance (i.e., software design error, 

process out of specifications, employee error, user 

misuse, etc.)? What evidence does the firm have to 

support the determination?

4. Did the firm determine if the nonconformance resulted 

in an injury or death? 

5. If a component, at least partly, caused the defect, 

determine if the same component was used in other 

devices manufactured by the firm. If so, has the firm 

conducted an analysis to assure the defect in the 

component will not have a deleterious effect on the 

operation of the other device(s)?

6. If a component was responsible for the device defect, 

what other device manufacturers use the same component (and especially the same lot number of the 

component)? Has the manufacturer of the recalled 

device notified the component manufacturer? Has the 

component manufacturer contacted its other customers 

about the problem?

7. Why was the component defective? Did the manufacturer of the component change the specifications without notifying the finished device manufacturer? Did the 

component fail to meet its release specifications?

NOTE: A visit to the component manufacturer may be 

needed to adequately answer questions 5, 6 and 7. 

Before doing so, confirm with CDRH and your supervisor that the matter is egregious enough to warrant this 

"next step."

8. Did the finished device manufacturer have an incoming 

component/raw material sampling and testing procedure? If not, why not?

9. If the manufacturer recalled the device because the 

labeling was inaccurate, or the wrong labeling was applied to the device (label mix-up), determine the following:

a. What quality system procedures should have been 

established to prevent the problem?

b. If the label or instructions for use were inaccurate, 

was the inaccuracy introduced in the design stage, 

or was it due to a printing problem?

10.If the device has been on the market for a year or more, 

and the manufacturer claims the problem is the result of 

design:

a. Determine why the problem was not detected earlier.

How many reports concerning the problem did the 

firm receive before deciding a recall was necessary? 

Does the firm have a procedure established for determining if a recall is necessary, and if so, did it 

follow the procedure? Obtain a copy of the procedure.

b. If the firm doesn't provide rational answers to the 

above questions, determine if they explored other 

possible causes for the problem.

c. Was the design feature that caused the problem included in the design of the device that was the 

subject of a premarket submission?

d. If the design feature that caused the problem is part 

of the original design, did the manufacturer recall all 

products manufactured since the device was 

introduced to the market? If not, why not?

e. If the problem was introduced via a design change, 

did the manufacturer follow established design 

change or change control procedures? If yes, are the 

procedures adequate? Was the nature of the 

problem such that it should have been anticipated, 

and the design verification/ validation study fashioned to detect the problem?

f. Has the manufacturer recalled all products distributed since the design change was introduced? If not, 

why not?

7.2.3.2 - Corrective Action

1. Describe the corrective action taken to correct the 

immediate problem, e.g., redesign, modify SOP, process validation, etc.

2. Did the firm qualify/validate the corrective action?

3. Did the firm establish responsibility to assure that the 

corrective action would be implemented and satisfactorily completed?
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4. What action did the firm take to prevent recurrence of

the nonconformance, e.g., training, increased process 

monitoring, etc.? 

5. Was the nonconformance information provided to those 

responsible for the areas in which the nonconformance 

occurred?

6. Did the firm determine if the nonconformance extended 

to other devices?

7. Did the firm determine if changes were needed in procedures and, if so, did it validate and implement the 

changes?

8. Has the manufacturer taken appropriate corrective action?

7.2.3.3 - Complaint and Medical Device 

Reporting (MDR) Reporting

Determine if adequate complaint investigations were performed as required by 21 CFR 820.198 (b). Also, determine 

if the investigation verified the complaint was a failure of the 

device to meet any or all of its specifications.

For complaints related to the recall, the firm should have 

made a determination whether the events are MDR 

reportable. Any event associated with a death or serious 

injury must be reported under MDR. Malfunctions likely to 

cause or contribute to a death or a serious injury are also 

reportable under MDR. Document the firm's explanations 

for the events they believe are nonreportable. Failure to 

submit required MDR reports are violations, and should be 

listed on the FDA-483 at the completion of the inspection.

Provide adequate documentation with the EIR to crossreference complaints with associated MDRs.

Device Information - Obtain the 510(k) or PMA number for 

each device under recall. If there is no 510(k) or PMA, 

determine if the device is a pre-enactment device (i.e., in 

commercial distribution prior to May 26, 1976). If multiple 

devices are being recalled, obtain this information for each 

device model or catalog number under recall.

7.2.4 - DRUG RECALLS

7.2.4.1 - Recalls of Human Drug Products

If the recalled product is covered by a New Drug Application 

(NDA) or Abbreviated New Drug Application (ANDA), 

determine if the defective product involves the type of 

problems shown under CFR 314.81 (b)(1)(i) and (ii). Also 

note whether or not the firm reported the problem to the 

FDA Division office that is responsible for the firm within 3 

working days of its receipt of the information, as required 

by that section.

7.2.4.2 - Recalls of Veterinary Drug Products

Veterinary Drug Products recalls are classified by, and 

health hazard evaluations are obtained through, CVM's 

Division of Drug Compliance. To inquire about specific 

veterinary drug product recalls or to obtain information on 

how to proceed, email CVM Recalls at 

CVMRecalls@fda.hhs.gov . 

7.2.5 - HUMAN CELLS, TISSUES, AND 

CELLULAR AND TISSUE BASED PRODUCTS 

(HCT/Ps) FOR IMPLANTATION, TRANSPLANTATION, INFUSION, OR TRANSFER

The FDA may consider an order of retention, recall, 

destruction, or cessation of manufacturing when any of the 

conditions specified in 21 CFR 1271.440 (a)(1) to (3) exist. 

The conditions include an agency finding that:

1. The HCT/P is infected or contaminated so as to be a 

source of dangerous infection to humans; or

2. An establishment is in violation of the regulations in this 

part and, therefore does not provide adequate 

protections against the risks of communicable disease 

transmission.

In addition to the conditions noted above, the agency may 

issue an order of cessation of manufacturing until 

compliance with the regulations has been achieved, as 

stated in 21 CFR 1271.440 (a)(3), when the FDA 

determines there are reasonable grounds to believe there 

is a danger to health. An order to cease manufacturing 

would be issued where violations create an urgent situation 

involving a communicable disease, because an 

establishment is in violation of the regulations in Part 1271 

and, therefore, does not provide adequate protections 

against the risks of communicable disease transmission. 

An order to cease manufacturing is a remedial action taken 

to put important protections in place to prevent 

communicable disease transmission.

NOTE: FDA will not issue an order for the destruction of 

reproductive HCT/Ps, nor will FDA carry out such 

destruction itself (21 CFR 1271.440 (f)).

7.2.6 – TOBACCO PRODUCT RECALLS

When you become aware of, or obtain information about, a 

possible tobacco product recall, contact the Center for 

Tobacco, Office of Compliance and Enforcement, Division 

of Enforcement and Manufacturing. See CTP's intranet site 

for contact information. 

http://inside.fda.gov:9003/CTP/ucm249908.htm

7.2.7 - SAMPLE COLLECTION

Collection of samples for regulatory consideration is at the 

discretion of Division management. Consult your 

supervisor and/or compliance branch for guidance. If a 

sample is indicated, only collect documentary samples for 

electronic products or medical devices, unless otherwise 

instructed.

If, after consulting with the Centers and Division 

Management it is determined that an official sample 

should be collected, ship an appropriate sample as 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 7

7-7 

directed by the Center and your Division. Keep the Center 

informed on the status of the shipment.

SUBCHAPTER 7.3 - MONITORING RECALLS

7.3.1 - INSPECTIONS TO MONITOR RECALL 

PROGRESS

It may be necessary to inspect the firm between the recall

initiation and the termination of a recall for several reasons 

including: to monitor the recall’s progress, verify product

disposition, or conduct a reconciliation of the distribution 

records for the recall. An inspection may also be assigned 

by your division if the Division Recall Coordinator requires 

assistance collecting necessary information from a firm, 

and the recall is potentially class I or significant class II. 

These visits are limited inspections on an as-needed basis.

Issue an FDA-482Notice of Inspection and collect needed 

information. During these inspections, remind recalling 

firms to submit periodic status reports to FDA. See 21 CFR 

7.53.

7.3.2 - FDA RECALL AUDIT CHECKS

NOTE: Do not conduct recall audit checks at DOD and VA 

facilities, as the FDA has a Memorandum of 

Understanding with them, and they have their own 

procedures for recalls.

7.3.2.1 - Definition

A recall audit check is a personal visit, telephone call, letter, 

or a combination thereof, to an account of a recalling firm, 

or a user or consumer in the chain of distribution. It is 

conducted to verify consignees at the recall depth specified 

by the strategy have received notification about the recall 

and have taken appropriate action.

7.3.2.2 - Level of Audit Checks

Conduct the number of audit checks requested in your 

assignment. If you are unable to do so, contact your 

supervisor for further instruction.

7.3.2.3 - Conducting a Recall Audit Check

The purpose of a recall audit check is to confirm the 

account received the recall notification from the notifying 

firm and followed all instructions included in the 

notification. The notifying firm may be the recalling firm, or 

a downstream account that received the recalled product 

and is conducting a sub-recall (such as a distributor). 

Notifications sometimes come in through other means, for 

example an automated notification system sent to 

hospitals. These other means are not considered to be an 

official notification of the recall, as the recalling firm, or a 

downstream account, did not directly contact the 

consignee.

Prior to conducting a recall audit check, review the recall 

audit check assignment given to you. Your assignment will 

contain the necessary details of the recall, recall strategy, 

and a list of accounts to be audited (Please Note: The 

assignment may list specific accounts to be audited or 

may provide a list of accounts to choose from). Conduct 

the audit check by the due date provided in the 

assignment. Pay particular attention to the type of product 

recalled, the labeling of the product, and the recall 

notification attached to the assignment which the recalling 

firm sent to their accounts. Take note of the depth of the 

recall listed in the assignment (i.e., wholesale, retail, 

consumer level). Your responsibility is to verify the 

account received the same recall information, they 

followed the instructions in the recall notification, and that 

the recall has been carried out to the appropriate depth 

listed in the assignment. The assignment will include how 

checks will be conducted, i.e., visit, phone calls, email, 

etc. as well as detailed instructions specific to the recall. 

Do not conduct recall audit checks by visit at consumer 

homes unless specifically directed in your assignment. If 

the assignment is for email audit checks, please use the 

email audit check template provided in the assignment. 

During your review of the assignment, try to gain an 

understanding of the list of accounts, and whether those 

listed actually received or may have received the recalled 

lot. This information affects the endorsement for the audit 

check. If the list is specific to the recalled product lot, the 

account should have received it. If the list is not so specific, 

or the account you are auditing does not know or remember 

if they received the recalled lot, the account should still 

follow the instructions in the recall notification and initiate a 

sub-recall of the product, if needed. This information affects 

the endorsement of the recall (see section 7.3.2.6 

Endorsing the Recall Audit Check). It is appropriate to 

challenge the account if the distribution list is included with 

the assignment includes them as a consignee for the 

specific recalled lot, and they say they never received the 

product.

When initiating a recall audit check, attempt to make 

contact with an individual at the account who has 

knowledge of the receipt of recall notifications and the 

disposition of recalled products. In hospitals, this 

responsibility may be held within the Risk Management or 

Safety departments. PLEASE NOTE: In the case of an 

audit check at the consumer level, attempt to verify you are 

speaking with the individual who was indicated as having 

received the product before disclosing the name of the 

recalled product and verifying they received notification of 

the recall.

If the account did not have any knowledge of the recall prior 

to your recall audit check, inform them of the recall, provide

them with a copy of the press release (if available) and 

recall notification letter, encourage them to follow the recall 

instructions, and document that you did so. DO NOT give 

the account a copy of your recall assignment.

If your audit check discloses the account did not follow the 

recall instructions (for example, recalled product being held 

for sale, or a requested sub-recall has not been initiated), 

encourage the account to follow the recalling firm’s 

instructions. If the account chooses not to follow the recall 

instructions, document the title/responsibility of the 
CHAPTER 7 INVESTIGATIONS OPERATIONS MANUAL 2023 

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individual at the account who chose not to follow the recall 

instructions and reason.

When you conduct an audit check by visit, it is important to 

examine the storage sites where the recalled product is 

stored and check the shelf stock to ensure all recalled 

product has been identified, removed from areas of use, 

and properly quarantined or destroyed/corrected. This is 

especially important in Class I recalls. 

For some recalls, the strategy may be a correction instead 

of a removal. Recall audit check assignments for field 

corrections may instruct you to verify that either the field 

correction has been completed, or to assess whether the 

recalling firm issued the initial instructions to discontinue 

and/or modify the use of the product, and the account 

followed those instructions. Detail the status of the 

correction in the remarks section of your form FDA 3177. 

If you encounter a refusal to permit entry or provide 

information during a recall audit check, document the name 

and title of the individual who refused, and the reason why 

they refused the audit check. Contact your supervisor for 

additional instruction.

FDA has a contract with a third party to conduct recall audit 

checks on behalf of the FDA. Any questions you or the firm 

may have regarding the third-party contract should be 

directed to OSPOP/DE/ROB at orarecalloe@fda.hhs.gov. 

There are also other entities conducting audits (e.g., state 

investigators conducting audits as part of their state duties 

or on behalf of the FDA, private firms who conduct audits 

on the behalf of a recalling firm) 

If during your audit check you find that the consignee used 

the FDA regulated product to manufacture USDA-regulated 

product, distributed product to a USDA facility, or the 

product was used in or procured for one of the USDA 

nutrition programs (i.e., National School Lunch Program),

complete the recall audit check. Provide the information to 

your Division Recall Coordinator, who will forward it to 

OSPOP/DE/ROB, who will share it with the USDA. If during 

your audit check you find that the consignee is a DoD 

supplier and/or used the FDA regulated product to 

manufacture DoD products, complete the recall audit 

check. Provide the information to the FDA Liaison to DoD 

as per IOM section 3.2.3 – DEPARTMENT OF DEFENSE 

(DoD), 3.2.3.6.1 – DoD/FDA Liaisons; the FDA Liaison will 

forward it to the DoD Liaison and appropriate 

ORA/OSPOP/DE/ROB contact.

During your audit check, verify that the consignee has 

conducted a sub-recall to the level specified in the 

assignment. If the consignee is unsure if he or she handled 

the recalled product, then collect the distribution list. Inform 

the consignee that a sub-recall may be necessary. If an 

account has not conducted a sub-recall, follow the 

procedures outlined in "Exhibit 7-3, #7."

Conduct sub-recall audit checks to the level specified in the 

assignment. Sub-recall audit checks may be made by 

telephone for accounts in another division, in lieu of 

creating a separate recall audit check assignment for that 

division to conduct the sub-recall audit checks.

7.3.2.4 - Audit Check Reporting

The results of your audit check should be reported on a 

form FDA 3177, "Recall Audit Check Report" form. See 

IOM Exhibit 7-3. It is preferred that Divisions complete the 

form FDA 3177 electronically. Divisions have the option of 

completing the form FDA 3177 electronically or as a hard 

copy. Directions for completing the form FDA 3177 can be 

found in Exhibit 7-3. Conducting the Recall Audit Check. 

The form FDA 3177 will be routed through your supervisor 

to the recall coordinator at the division monitoring the recall, 

who will store the official signed form in the recall file.

Identified exhibits should be submitted with your FDA 3177.

Identify each page or file with the following information:

- RES Event number (as listed in your assignment)

- Direct account name or sub-account name, 

whichever is applicable

- Investigator’s initials and date of the audit check

- Exhibit and page numbers

FACTS allows you to enter the amount of time spent 

conducting your audit check. When you complete a recall 

audit check, you should report your time using the 

"Miscellaneous Operations Accomplishment Hours" screen

using the code OP 17. 

Submit one OP 17 per RES event. In the Assignees 

Accomplishment Hours block of the Miscellaneous 

Operations screen, enter the FEI of the recalling firm and 

for the “#Ops” enter the number of separate audit checks 

conducted.

7.3.2.5 - Ineffective Recalls

An audit check is considered ineffective if one of the 

following conditions were found:

A. The account did not receive formal notification from 

the notifying firm. Note: in instances where the 

account was not formally notified but still took action 

based on information learned about the recall from 

a source other than the notifying firm, the audit 

check is still ineffective.

B. The account did not follow the instructions provided 

by the notifying firm. If the account is not sure if they 

received the recalled lot(s), they should still follow 

the instructions in the notification.

C. The account distributed the recalled product, but did 

not conduct a sub-recall, if applicable.

D. The account received the type of product under 

recall, cannot determine whether they received the 

specific recalled lots, and did not conduct a sub 

recall. The account should still conduct a sub recall 

if there is any possibility that they received the 

recalled lot(s). 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 7

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7.3.2.6 Endorsing the Recall Audit Check

Recall audit checks should be endorsed by the Supervisory 

Investigator based on the information collected during the 

audit check. 

The audit check should be endorsed based on conditions 

found when the audit check was conducted and not based 

on the account’s actions to correct ineffectiveness. Choose 

the endorsement that is best described by one of the 

scenarios below.

An audit check should be endorsed “Effective” if the 

account was notified of the recall by the appropriate 

notifying firm and followed, or is in the process of following, 

the instructions in the recall notification. Please note: If you 

selected “No” for question 5a or 6a on the 3177, you cannot 

endorse the 3177 as “Effective”. If both 5a and 6a on the 

3177 are “Yes”, the 3177 should be endorsed as “Effective”

The following are examples of ineffective recall audit 

checks: 

A. “Ineffective – Notifying Firm”

• The account did not receive formal notification from 

the notifying firm. Note: in instances where the 

account was not formally notified but still took 

action based on information learned about the 

recall from a source other than the notifying firm, 

the audit check is still ineffective.

B. “Ineffective – Consignee”

• The account did not follow the instructions provided 

by the notifying firm. If the account is not sure if they 

received the recalled lot(s), they should still follow 

the instructions in the notification. 

• The account distributed the recalled product, but 

did not conduct a sub-recall, if applicable.

• The account received the type of product under 

recall, cannot determine whether they received the 

specific recalled lots, and did not conduct a sub 

recall. The account should still conduct a sub recall 

if there is any possibility that they received the 

recalled lot(s).

Your Division’s Recall Coordinator can assist you if you 

need help evaluating if an account must conduct a subrecall. In some instances, (e.g., field corrections) the 

effectiveness of the recall audit check may be determined 

by the assignment and discussion with the recall 

coordinator.

If the account assigned for a recall audit check is out of 

business, endorse the audit check as “Out of Business”.

Endorse as “Other” on very rare occasions, such as if the 

account cannot remember whether or not they received the 

recall notification and does not carry the recalled product.

7.3.3 - RECALL TERMINATED/RECALL 

COMPLETED

7.3.3.1 - Definitions

Recall Terminated - A recall will be terminated when the 

FDA determines that all reasonable efforts have been made 

to remove or correct the violative product in accordance 

with the recall strategy, and when it is reasonable to 

assume that the product subject to the recall has been 

removed and proper disposition or correction has been 

made commensurate with the degree of hazard of the 

recalled product. Written notification that a recall is 

terminated will be issued by the appropriate Division office 

to the recalling firm.

Recall Completed - For monitoring purposes, the FDA 

classifies a recall action "Completed" when all outstanding 

product, which could reasonably be expected is recovered, 

impounded, or corrected.

7.3.3.2 - Closeout Inspection

Some recalls may require a limited inspection at the 

recalling firm as a final monitoring step to verify the recall 

has been completed. A memorandum or limited EIR should 

be prepared. See RPM Chapter 7, Attachments B1, 

“Recommendation for Recall Classification and 

Termination” and Attachment C, “Recall Termination or 

Recommendation for Termination” for the format. Portions 

of this format (i.e., Section II and certain items in Section 

III) will be completed by your supervisor, Recall

Coordinator, or compliance officer, depending upon your 

Division's policy.

During the closeout inspection, you should witness 

destruction or reconditioning of the recalled product, when 

possible, when unable to do so, obtain written 

documentation from the firm and/or any state or local 

government agencies that may have witnessed or 

otherwise verified product disposition. The disposal of large 

amounts of contaminated or hazardous items may require 

the firm to file an Environmental Impact Statement (EIS), or 

pre-disposal processing to render the goods harmless. Do 

not agree to witness destruction without resolution of these 

issues. Obtain a "Letter of Voluntary Destruction" from the 

firm whenever you witness this operation. See IOM 2.6.4.1.

SUBCHAPTER 7.4 - SPECIAL RECALL 

SITUATIONS

7.4.1 - General

There are several special recall situations which may 

require you to deviate from the normal recall procedures. 

Seek your supervisor's or R&E Coordinator's guidance on 

these. Examples include:

1. Products in the possession of U.S. Defense 

Installations; 

2. NDA and ANDA withdrawals; 
CHAPTER 7 INVESTIGATIONS OPERATIONS MANUAL 2023

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3. National Academy of Science (NAS)/Nuclear 

Regulatory Commission (NRC) (DESI) recalls of drugs 

judged ineffective; and

4. Recalls involving jurisdiction of more than one Federal 

Agency (e.g., FDA/EPA, FDA/Consumer Product 

Safety Commission (CPSC), etc.).
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 7-1 

7-11

7-1 RECALL COMMUNICATIONS EXAMPLE 

MODEL DRUG RECALL LETTER

[Company Letterhead]

(in red print) URGENT: DRUG RECALL – Nonsterile injectable

[Date]

[Contact name or Department]

[Firm Name]

[Address]

Dear [wholesaler, retailer, consumer]:

This is to inform you of a product recall involving: [Brand Name (generic) dosage form, strength, description and size of 

packaging, NDC or UPC codes, lot numbers]

See enclosed product label for ease in identifying the product at the [wholesale/ retail/ user level].

This recall has been initiated due to [describe problem and how it was discovered]. [Use/Consumption] of this product 

may [describe any potential health hazard].

This product was shipped between [range of distribution dates] or This product was shipped to you on [date]. [If 

possible, provide consignee with shipping dates and quantities shipped.]

Immediately examine your inventory and quarantine product subject to recall. [If this is a retail or user level recall, 

include the following] In addition, if you may have further distributed this product, please identify your customers and 

notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of 

this recall notification letter [or Enclosed is a letter you should use in notifying your customers should you choose to 

create a separate letter.]

[Your notification must include instructions on what customers should do with the recalled product.]

You will be reimbursed by check or credit memo for the returned goods and postage.

Please return the enclosed card immediately providing the requested information. If you have any questions, call 

[name] at [phone number] [days of week] between [start time] am to [end time] pm [state time zone].

This recall is being made with the knowledge of the U.S. Food and Drug Administration. The FDA has classified this 

recall as class _____ (if classified).

We appreciate your assistance.

John Doe 

President
EXHIBIT 7-1 INVESTIGATIONS OPERATIONS MANUAL 2023 

7-12

PLEASE FILL OUT AND RETURN

We do not have any stock of List 1234, Cyanocobalamin

Injection Lot No. 4321 on hand

We have requested our accounts to return their stocks of this 

merchandise to us.

We are returning _________ bottles of List 1234, Lot No. 4321

Name . 

Address . 

First Class

Permit No. 2

BUSINESS REPLY MAIL

No Postage Stamp Necessary if mailed in U.S.A.

Postage will be paid by:

JOHN DOE LABORATORIES

Somewhere, U.S.A. 12345-0909

Henry Doe
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 7-1

7-13

JOHN 

DOE LABORATORIES FIRST CLASS MAIL

A. B. C. PharmacyAnywhere U. S. A.

(red print) URGENT DRUG RECALL
EXHIBIT 7-2 INVESTIGATIONS OPERATIONS MANUAL 2018

7-14

7-2 FORM FDA 3177 RECALL AUDIT CHECK REPORT
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 7-3

7-15

7-3 Instructions for Completing the FDA 3177 Recall Audit Check Report

Completing the FDA 3177 Recall Audit Check Report Form

Note: Obtain as much information as possible in order to successfully complete the FDA 3177 Recall Audit Check 

Report Form as follows: 

1. RECALL INFORMATION

a. RES NUMBER – Enter the Recall Enterprise System (RES) number as listed in your assignment.

b. RECALLING FIRM – Provide the name and address of the firm listed in your assignment as the recalling firm.

c. RECALLED CODE(S) – Provide the lot, batch, or serial number indicated as the recalled product in your assignment. 

If there are more numbers than can fit in the space, state that there are numerous lots under recall and refer to the 

assignment. 

d. PRODUCT(S) – Provide the name of the recalled product as indicated in your assignment. If numerous products are 

involved, use a generic term (such as ice cream, dried fruit, etc.).

2. PROGRAM DATA – Complete as per division policy.

a. MONITORING DIVISION – Enter the monitoring division as listed in your assignment. The monitoring division is 

often the division where the recalling firm is located, and is responsible for evaluating the effectiveness of the entire 

recall.

b. FEI NUMBER OF RECALLING FIRM – FEI number of the recalling firm as listed in your assignment.

c. PAC CODE – PAC code given in your assignment. 

d. HOURS – has been removed from the 3177, but operational hours should still be entered into FACTS as instructed in 

IOM section 7.3.2.4.

3. AUDIT ACCOUNTS

Do not add any text to the sub-account or tertiary account fields (3a and 3b) if you are not reporting audit 

check information for these downstream accounts. Adding text (such as N/A) to these fields impacts how RES 

reads the form.

a. DIRECT – The name, address, and telephone number of the account that was listed in your assignment as receiving 

the product directly from the recalling establishment. This may or may not be the same account at which you are 

conducting your audit check. 

b. SUB-ACCOUNT (SECONDARY) – If the Direct account indicates the recalled product(s) were further 

distributed, complete this section for each sub-account audited as well as the DIRECT account section with the name, 

address, and telephone number of the applicable establishments. 

c. SUB-ACCOUNT (TERTIARY) – If the Secondary account indicates the recalled product(s) were further

distributed, complete this section for each sub-account audited, the SUB-ACCOUNT (SECONDARY) section, and the 

DIRECT account section with the name, address, and telephone number of the applicable accounts.

4. CONSIGNEE DATA
EXHIBIT 7-3 INVESTIGATIONS OPERATIONS MANUAL 2023

7-16

Contacted by: The method used to conduct the audit check (check the appropriate box). 

a. NAME OF PERSON CONTACTED & TITLE – The name and title of the person at the account being audited who 

provided the most information during the audit check.

b. TYPE CONSIGNEE – The type of establishment at which you are conducting your audit check (check the 

appropriate box – if none, check “Other” and describe the type of establishment). 

c. DOES/DIDTHE CONSIGNEE RECEIVE THE RECALLED PRODUCT? – If the account at which you are 

conducting the audit check never received the recalled product, indicate “No”. If the account received or may have 

received the recalled product, indicate “Yes”. This includes if the company is unsure they received the recalled lot.

5. NOTIFICATION DATA

a. FORMAL RECALL NOTICE RECEIVED? – Indicate if the account received formal notification of the recall (check 

the appropriate box). Formal notification may be received from the recalling firm, direct account or the 

secondary/tertiary firm. If notification is received informally e.g. press release, subscription service, or social media, 

indicate “No” and explain in Remarks how the account received notification. If there is some reason why you cannot 

determine if a notification was received (for example, it may have been discarded) indicate “Cannot be determined” and 

explain in Remarks. 

b. RECALL NOTIFICATION RECEIVED FROM – The firm that formally notified the account at which you 

are conducting your audit check (check the appropriate box). 

c. DATE NOTIFICATION RECEIVED – Date the account received the formal notification. 

d. TYPE OF NOTICE RECEIVED – How the formal notification was received (letter, phone, e-mail, automated 

messaging system, etc.). 

6. ACTION AND STATUS DATA 

a. DID CONSIGNEE FOLLOW THE RECALL INSTRUCTIONS? – If the account followed or is following all of the 

recall instructions prior to your audit check, indicate “Yes”. If the account did not follow or has not begun to follow the 

recall instructions prior to your audit check, indicate “No”. Explain what was/was not done in Remarks, and if the 

account took action as a result of your audit check. 

b. AMOUNT OF RECALLED PRODUCT ON HAND AT TIME OF NOTIFICATION – The amount of recalled 

product the account had at the time they received formal notification from the notifying firm. 

c. CURRENT STATUS OF RECALLED ITEMS – Indicate the status of the recalled items at the account at the time of 

your audit check (check the appropriate box). If the recalled product is still being held for sale/use, or was being held for 

return/correction, ensure that the account properly quarantined the product (if applicable) and followed the recall 

instructions. In the case of a medical device recall with instructions that permit the device to remain in use awaiting 

correction or servicing of the device, mark “was still held for sale/use”. Include details of the product status in the 

Remarks 

d. DATE AND METHOD OF DISPOSITION – Indicate the date and method the recalled product was 

destroyed/returned/corrected. 

7. SUB-RECALL NEEDED? – If during the course of an audit check, you find the recalled product has been further 

distributed, and your audit check for the recall has not reached the depth indicated in your assignment, a sub-recall may 

be needed. For example, if your assignment indicates the recall depth is at the retail level, and you are auditing a 

wholesaler, the wholesaler should conduct a sub-recall to reach the retail level. 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 7-3

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In the case of a sub-recall, collect distribution of the recalled product, the sub-recall notification, and any other pertinent 

information to attach to your form FDA 3177. Carry out the recall audit check to the depth indicated in the assignment. 

Determine if the consignee followed the instructions and conducted a sub-recall. If they did not, then inquire with the 

consignee about their willingness to continue the recall to the depth specified in the recall strategy and gather as much 

distribution information as possible. Indicate “Yes” in this section and add as much detail as possible in Remarks. 

In some cases, if the consignee has re-labeled, repackaged, or remanufactured the recalled product, a new recall may be 

needed instead of a sub-recall. However, a new recall may not be needed, if the consignee has manipulated the recalled 

product in a way that corrects the initial reason for the recall (e.g. if the consignee re-labels the product so the labeling

issue is no longer a concern, or if the consignee heat treats the product adequately to eliminate the hazard causing the 

original recall). 

If you determine a new recall is needed, or are unsure, collect all relevant information, including labeling to be 

evaluated with the assistance of your division’s Recall Coordinator (refer to section 7.3.2.4 for labeling instructions of 

attachments). 

Indicate “No” in this section if the product has not been further distributed and your evaluation finds that a sub-recall is 

not necessary. 

8. AMOUNT OF RECALLED PRODUCT NOW ON HAND – The amount of recalled product still at the account 

during your audit check. 

9. INJURIES/COMPLAINTS 

a. IS CONSIGNEE AWARE OF ANY INJURIES, ILLNESS, OR COMPLAINTS? – Ask the consignee if they have 

firsthand knowledge of any injuries, illness, or complaints pertaining to the recalled product. Collect relevant 

information and route per division procedures. 

10. REMARKS – Use this section to provide details that could not be addressed in the previous sections, or to give 

additional information. If you need additional space for remarks or other information, attach a written document to the 

3177 and reference the attachment in the remarks section. 

CHECK – Place a handwritten or electronic signature, followed by your name and title printed or typed, the date your 

audit check completed, and your division. 

ENDORSEMENT – Follow section 7.3.2.6 Endorsing the Audit Check. Please note: If you selected “No” for question 

5a or 6a on the 3177, you cannot endorse the 3177 as “Effective”.

If changes need to be made after the document has been signed, the signer needs to clear the electronic signatures by 

right clicking on the signature and pressing “clear signature”. Then the form can be modified and re-signed.