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ORA Laboratory Manual Volume III Section 5

Document Number:

III-05

Revision #: 02

Revision Date:

08/13/2019

Title: 

Analysts on Inspection Page 1 of 29

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Sections in This Document

1. Historical Background and the Law ........................................................................................... 1

2. Analysts on Inspection ............................................................................................................... 3

2.1. Preparing for an Inspection ............................................................................................. 3

2.2. Starting an Inspection...................................................................................................... 5

2.3. Regulatory Notes and Exhibits ........................................................................................ 5

2.4. Inspections and Travel .................................................................................................... 6

2.5. Sample Collection............................................................................................................ 7

3. Types of Inspections .................................................................................................................. 7

3.1. Food Inspections ............................................................................................................. 8

3.2. Drug Inspections............................................................................................................ 11

3.2.1. General Areas (Chemistry and Microbiology Inspections)............................. 11

3.3. Team Inspections versus Solo Contract Laboratory inspections ................................. 21

4. Establishment Inspection Reports ........................................................................................... 22

5. FDA-483 Objectionable Conditions and Practices .................................................................. 24

6. eNSpect.................................................................................................................................... 24

6.1. Operating as the Lead Investigator ............................................................................... 25

6.2. Operating as Part of a Team Inspection ....................................................................... 25

6.3. Writing FDA-483 Observations in eNSpect................................................................... 25

6.4. Writing the Establishment Inspection Report in eNSpect............................................. 26

7. Computerized Systems and Electronic Records ..................................................................... 26

8. Helpful References Pages on the Internet or Intranet ............................................................. 27

9. Document History..................................................................................................................... 28

10. Change History......................................................................................................................... 28

11. Attachments.............................................................................................................................. 29

1. Historical Background and the Law

FDA's primary duty is that of a public health agency charged with the 

protection of the health of American consumers with regard to the safety and 

efficacy of foods, drugs, cosmetics, biologics, medical devices and radiological 

products. 

The Agency's statutory requirements, defined primarily by the Food, Drug, and 

Cosmetic Act, (FD&C Act) were promulgated to ensure that consumers are 
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protected against unsafe products, and from the adverse health or economic 

consequences of false or misleading labeling. This is often accomplished by 

an inspection of the facility. FDA’s authority to conduct an establishment 

inspection is found under Section 704 of the Act: 

https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFood

DrugandCosmeticActFDCAct/FDCActChapterVIIGeneralAuthority/default.htm

SEC. 704. [374] “employees duly designated by the Secretary, upon 

presenting appropriate credentials and a written notice to the owner, operator, 

or agent in charge, are authorized (A) to enter, at reasonable times, any 

factory, warehouse, or establishment in which food, drugs, devices, or 

cosmetics are manufactured, processed, packed, or held, for introduction into 

interstate commerce or after such introduction, or to enter any vehicle being 

used to transport or hold such food, drugs, devices, or cosmetics in interstate 

commerce; and (B) to inspect, at reasonable times and within reasonable limits 

and in a reasonable manner, such factory, warehouse, establishment, or 

vehicle and all pertinent equipment, finished and unfinished materials, 

containers, and labeling therein. 

A separate notice shall be given for each such inspection, but a notice shall 

not be required for each entry made during the period covered by the 

inspection. Each such inspection shall be commenced and completed with 

reasonable promptness.

Upon completion of any such inspection of a factory, warehouse, consulting 

laboratory, or other establishment, and prior to leaving the premises, the officer 

or employee making the inspection shall give to the owner, operator, or agent 

in charge a report in writing setting forth any conditions or practices observed 

by him which, in his judgment, indicate that any food, drug, device, or cosmetic 

in such establishment (1) consists in whole or in part of any filthy, putrid, or 

decomposed substance, or (2) 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.” 

21 Code of Federal Regulations (CFR) 113 and 21 CFR 114 requires 

commercial processors of LACF and acidified foods to maintain complete 

records of processing, production, and initial distribution of these food 

products. 21 CFR 108.35(h) and 21 CFR 108.25(g) provide that a commercial 

processor shall permit the inspection and copying of these records by duly 

authorized employees of the FDA. 

https://www.gpo.gov/fdsys/search/submitcitation.action;jsessionid=KFHBPYSN

S8LVSW6Cz8mC9TPnlQw1Q8jY8q109yW9TytmpGh9KLZF!-

1869614850!1418187217?publication=CFR. The Demand for Records (FDA 

482a) must identify the specific records requested and must be signed by the 
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investigator. It should be noted that FDA inspections do not extend to financial 

data, sales data, other shipment data, and research data (other than data for 

drugs, antibiotics, and reporting).

2. Analysts on Inspection

During the course of an analyst’s career with FDA, they will often be expected 

to participate in the inspection of FDA regulated firms. Analysts bring scientific 

expertise, knowledge, and other skills to an inspection team. Participation may 

include making and recording observations to evaluate the firm’s processes, 

practices and conditions; reviewing the firm’s records; asking questions of the 

firm’s management or employees; collection of samples; and participation in 

the discussion during the close out meeting or exit interview with the firm’s 

management. Often the analyst will assist in the preparation of sample 

collection reports, observations, and establishment inspection reports.

2.1. Preparing for an Inspection

A. An analyst on a team inspection lends scientific support and technical 

expertise to the inspection team. The type of team inspection that an 

analyst will participate in depends upon their area of expertise and the 

type or complexity of inspection being performed. Chemists, 

microbiologists, biologists, entomologists, sanitarians, biochemists, 

organoleptic specialists, and engineers all play an important role in a 

team inspection.

B. Prior to beginning a team inspection, preparation is key. Review the 

district files of the firm to be inspected and acquaint oneself with the 

firm's inspectional history, testing practices, and products. Review the 

previous Establishment Inspection Reports (EIRs) and FDA 483 items. 

Review the inspectional assignment in FACTS and note what Program 

Assignment Code (PAC) is listed in the assignment (this will enable the 

analyst to locate the corresponding Compliance Program). Meet with 

the Consumer Safety Officer (CSO) and other team members before 

beginning the inspection. Also, review any applicable Laws, 

Regulations, Compliance Programs, Compliance Policy Guides, and 

Inspectional Guidance documents relating to the type of team 

inspection being performed. Do not forget to read the Investigators 

Operational Manual (IOM). The IOM is the primary source of guidance 

regarding Agency policy and procedures for establishment inspections 

and sampling by field investigators and analysts. Knowing what the 

analyst role is, and what will be expected of each team member is 

crucial. 

C. To prepare for an inspection, an analyst will need to:
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1. Read the inspectional assignment to determine what is to be 

covered.

2. Review the File Jacket for the previous inspection(s); note previous 

deficiencies and if there were corrective actions.

3. Review previous EIRs and 483s.

4. Review the assigned Compliance Program.

5. Review the related sections of the CFR.

6. Review associated Guidance Documents. 

7. Ensure sample supplies are present and in good condition if the 

inspection requires sample collections.

A. Depending on the type of team inspection, general responsibilities may 

include reviewing analytical data from production, manufacturing or 

testing facilities; reviewing and evaluating test methods; and observing 

actual analytical testing or manufacturing being performed at the facility 

to assure that good manufacturing practices and good laboratory 

practices are being used. An analyst may need to evaluate whether 

laboratory equipment is properly calibrated or qualified. Also, an analyst 

may need to evaluate sanitation practices and environmental conditions 

that might affect safe product packaging and production.

B. During the inspection, an analyst may be asked to collect samples. 

Sampling operations are carried out using techniques to ensure that the 

sample is representative of the lot; that the sample of the product is in 

the same condition as it was before sampling, and that the collection 

technique does not compromise the compliance status of the lot. The 

type of samples that may be collected include in-line samples, 

environmental samples, sanitation samples, water samples, finished 

product samples, as well as the various controls associated with these 

samples. Read the corresponding Compliance Program and the IOM if 

samples are to be collected. For microbiological inspections, sampling 

products using aseptic techniques is critical. Aseptic sampling 

techniques are used to assure that the microbial load of a product is not 

increased or introduced by a poor sampling procedure. The use of 

sterile sampling implements and containers, as well as a prescribed 

sampling protocol ensures proper collection. 

C. Do remember that during the inspection, safety is paramount. When 

conducting an inspection, or collecting a sample at a firm, make sure 

that the proper protective clothing and safety equipment are used. The 

analyst may need to wear a jumpsuit, lab coat, safety glasses, safety 
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shoes, hard hat, hearing protection or respiratory protection. In a sterile 

drug facility, there may be precise gowning procedures. Guidance 

should be provided by the firm’s management. The analyst can also 

contact an ORS Industrial Hygienist or ORS Safety and Occupational 

Health management and discuss any concerns either prior to or during 

the inspection. The analyst will also need to discuss with the 

inspectional team and the firm’s management any allergies which may 

preclude participation in certain aspects of the inspection.

2.2. Starting an Inspection

A. A FDA-482 Notice of Inspection is presented to the most responsible 

person upon entering a firm. Credentials are also displayed at this time. 

The analyst will be expected to display their FDA credentials. Securing 

official credentials through a supervisor may take 1-2 weeks and is 

done prior to going on inspection. 

B. In the case of an international inspection, only credentials are displayed 

since the Notice is not issued. 

C. Analysts must secure an official passport prior to overseas travel. 

Depending on the country, an official visa may also be needed for entry 

into the country. 

D. The investigator will usually give a brief synopsis of why the inspection 

is occurring. In the case of a directed or for-cause inspection, the 

investigator may be vague. Do NOT add to the investigator’s comments 

unless discussed previously.

2.3. Regulatory Notes and Exhibits

A. During the inspection, notes are expected to be recorded in accordance 

with Subchapter 2.1 Regulatory Notes of the IOM. This subchapter 

identifies what should be included and what should not be included in 

inspectional notes or diary notebook. Keep in mind these notes are 

considered part of the inspection and are subject to the Freedom of 

Information Action (FOIA). A return address should also be located on 

the notebook in case it is lost. 

B. The inspectional notes are factual based upon what was reviewed and 

observed during the inspection. The analyst may want to document 

product names, batch numbers reviewed, names and titles of people 

spoken to during the inspection and who provided information, SOP 

numbers of the methods reviewed, raw material, in-process or finished 

product testing reviewed (e.g., purity assays, dissolution results, 

objectionable microorganism plate counts) or, the systems reviewed 

(e.g., sampling, water system testing, or environmental monitoring). 
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C. Exhibits are any documents collected during an inspection which are 

included in the EIR as evidence of observations. Exhibits should 

contribute to the objective of the assignment and the clarity of the 

report. In some cases, exhibits may be physical materials that 

constitute evidence for establishing violative conditions. These types of 

exhibits are prepared and submitted under an INV sample number. Inplant photographs are exhibits as well; however, they are submitted 

under seal in a FDA-525 envelope as an exhibit to the EIR or with a 

documentary sample.

D. During the inspection, it is best to collect photocopies of methods, 

results, standard operating procedures, schedules, etc. that may be 

used to assist in the description of a process or an objectionable 

condition. Documents not included in the report should be properly 

destroyed or shredded. Relate this practice to the firm at the time of 

collection. In the case of electronic file copies, the Division Office may 

have a policy addressing their disposal or the firm may request the 

return of the electronic files. Either way, state in the report how the 

electronic files were treated.

E. The "Exhibits" section of the EIR contains a list of all exhibits cited in the 

EIR. 

F. Each exhibit is labeled with the following: 

1. Exhibit number,

2. Name of the firm,

3. Firm FEI number,

4. Dates of the inspection,

5. Initials of the team member(s) submitting the exhibit, and

6. Number of pages in the exhibit.

G. In the EIR, they are listed with their reference number and a title or 

description. The lead investigator decides how exhibits will be 

numbered (i.e., whether the analyst's exhibits will be included with those 

of the investigator and numbered sequentially or included in a separate 

appended report and numbered separately).

2.4. Inspections and Travel 

A. Travel is outlined in the IOM in Subchapter 1.2 (Travel) under

CHAPTER 1 (ADMINISTRATION).
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B. There are many instances when an analyst will be requested to travel 

outside of the local travel area or to another Division. In these 

instances, the analyst needs to follow the Division/ ORS policies. If 

planning to stay overnight, the analyst will need to have a Travel 

Authorization prepared and have it approved PRIOR to the start of the 

travel. 

C. For on the road inspections, a lap top computer can be a very helpful 

tool to have at the inspectional location. With a lap top computer, 

reports can be worked on in the evenings and will allow the analyst to 

contact various resources for assistance after-hours. 

2.5. Sample Collection 

Sampling is outlined in the IOM under the chapter “SAMPLING.” This chapter 

explains the step by step process for collecting samples. Refer to Chapter 4 

(SAMPLING) for detailed instructions. It describes the types of samples 

typically collected during an inspection. A receipt for sample (FDA 484) is 

issued when collecting physical samples. This receipt is issued after the 

completion of the inspection but prior to leaving the premises. This process is 

clearly explained in sections 4.2.5 Receipt for Sample. In cases of 

documentary samples, there is usually a need for the issuance of an affidavit. 

Affidavits are explained in section 4.4.8 AFFIDAVITS. The form typically used 

is the FDA 463a. Affidavits are crucial since these documents are used to tie 

all the records collected to the objectionable conditions and show interstate 

transportation. Analysts who write affidavits should consult the Investigations 

or Compliance Branch for the proper style as well as review this section in the 

IOM.

3. Types of Inspections

An establishment inspection is a careful, critical, official examination of a 

facility to determine its compliance with laws administered by FDA. 

Inspections may be used to obtain evidence to support legal action when 

violations of the law are found or they may be directed to obtain information on 

new technologies, good commercial practices or data for establishing other 

regulations, etc. The kind and type of inspections conducted will normally be 

defined by a Center program or assignment. There are comprehensive and 

directed inspections. Comprehensive inspections direct coverage to 

everything in the firm subject to FDA jurisdiction while a directed inspection 

focuses on the areas described in the Center program or assignment. 

The types of inspections most analysts find themselves on are directed 

inspections of food or drug firms. On occasion, analysts will accompany 
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consumer safety officers on the inspection of cosmetics, medical devices, and 

animal feed firms.

3.1. Food Inspections

A. The Food, Drug, and Cosmetic Act (FD&C Act) provides protection of 

the public from products that may be deleterious, are unclean or 

decomposed, or have been exposed to insanitary conditions that may 

contaminate the product with filth or may render it injurious to health. A 

food microbiologist, entomologist, chemist or sanitarian may participate 

in a team inspection of food manufacturers in order to evaluate and 

document insanitary conditions (e.g., filth and microbiological 

contamination), decomposition, adulteration with pesticides and 

industrial chemicals, or illegal use of color or food additives.

B. There are specific current Good Manufacturing Practice (cGMP) 

regulations that must be followed by food processing facilities under 21 

CFR Part 110 “Current Good Manufacturing Practice in Manufacturing, 

Packing or Holding Human Food”. Analysts need to review and 

become familiar with this section of the CFR. In addition, analysts need 

to assess whether the water being used in contact with the product 

(contact water) is safe. Processing water includes water that is used for 

post-harvest treatment of produce, such as washing, cooling, waxing, 

and product transport. Water can be a carrier of many microorganisms 

including pathogenic strains of Escherichia coli, Salmonella, Vibrio 

cholerae, Shigella, Cryptosporidium parvum, Giardia lamblia, 

Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and 

Hepatitis A viruses. Even small amounts of contamination with some of 

these organisms can result in foodborne illness. Reusing processing 

water may result in the build-up of microbial loads, including undesirable 

pathogens from the crop.

C. Good Manufacturing Practices (GMPs) for water used for food and food 

contact surfaces in processing facilities are in Title 21 of the Code of 

Federal Regulations (CFR), sections 110.37(a) and 110.80(a)(1). 21 

CFR 110.19 provides an exemption from the requirements in 21 CFR 

part 110 for establishments engaged solely in the harvesting, storage, 

or distribution of raw agricultural commodities.

D. The analyst needs to evaluate whether food contact services are 

cleaned and handled properly. Food contact surfaces may be sanitized 

by a process that is effective in destroying or substantially reducing the 

numbers of microorganisms of public health concern, as well as other 

undesirable microorganisms, without adversely affecting the quality of 

the involved product or its safety for the consumer.
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E. The analyst will also need to assure that the facility has proper 

precautions in place to reduce the risk for food contamination or cross 

contamination, personal protection is being used, proper handling of 

toxic compounds is being performed, and health conditions and pests 

are being addressed.

F. Food sanitation team inspections may also involve an entomologist or 

food sanitarian. During a team inspection at a food warehouse, the 

entomologist or food sanitarian may be able to lend expertise in 

identifying or documenting insect infestation or rodent contamination of 

food products during warehouse storage. For example, documentation 

and identification of whole insects, excreta pellets, urine stains, insect 

damage, and insect and/or rodent gnawing will be needed to support 

certain regulatory actions.

G. A microbiological inspection demands a thorough understanding of the 

critical factors associated with the production and testing of the product 

being inspected. During the inspection, a microbiologist needs to fully 

identify the likely sources and possible routes of microbiological 

contamination which includes but is not limited to the handling of the 

product and environmental conditions. The microbiologist will need to 

document temperature abuses and delays in processing steps that will 

affect the product, evaluate microbial testing of the incoming product 

component(s) or of the finished product(s), and focus on positive 

findings of pathogenic microorganisms; determine if equipment is 

constructed or covered to protect contents from dust and environmental 

contamination; determine what equipment is present in the laboratory 

and if it is usable for the purpose intended. If the firm uses a consulting 

laboratory, determine what tests are performed and how often. Review 

laboratory records for the period immediately preceding the inspection.

H. One of the common types of team inspections a microbiologist may 

participate in are Low-acid canned food or Acidified food manufacturer 

inspections. The absence of oxygen, normal room temperature storage 

conditions, moisture and nutrients associated with low-acid foods favors 

growth of Clostridium botulinum. Failure to either destroy or control (by 

water activity or acidification) the germination and growth of spores of 

Clostridium botulinum because of improper manufacture, processing, or 

packing may result in the production of a toxin which causes the 

potentially fatal food poisoning known as botulism.

I. Low-acid canned foods and Acidified foods are subject to all of the 

requirements under the Federal Food, Drug, and Cosmetic Act and the 

Fair Packaging and Labeling Act. These laws require that foods be safe, 
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clean, and wholesome, and that labeling be honest and informative. The 

processing of Low-acid canned foods must comply with the 

requirements of the Good Manufacturing Practice regulations (21 CFR 

Part 113). The processing of Acidified foods must comply with the 

requirements of the Good Manufacturing Practice regulations (21 CFR 

Part 114). 

J. Sections 21 CFR 108 & 113 on Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed Containers, and 21 CFR 114 Acidified 

Foods are of particular importance when conducting these types of 

inspections. 

K. Another type of food inspection is a HACCP inspection. FDA's Seafood 

Hazard Analysis Critical Control Point (HACCP) program is set forth in 

21 CFR part 123. These regulations require processors of fish and 

fishery products to operate preventive control systems for human food 

safety that incorporate seven principles of HACCP. Processors must, 

among other things, establish "critical control points" in their operations 

where they can most effectively maintain the safety of their products, 

systematically monitor the operation of those critical control points to 

ensure that they are working as they should, and keep records of the 

results of that monitoring. Processors also must develop written HACCP 

plans that describe the details and operation of their HACCP systems. 

Each processor may tailor its HACCP system to meet its own 

circumstances. 

L. The regulations require processors to make their HACCP records and 

plans "for official review and copying at reasonable times" (§123.9 (c)). 

Finally, the regulations provide that fish and fishery products are 

adulterated under section 402(a) (4) of the Federal Food, Drug, and 

Cosmetic Act if their processor fails to have and implement a HACCP 

plan when one is called for, or otherwise fails to meet any of the 

requirements of the regulations, including allowing the official review of 

records (§123.6(g)). 

M. Another type of team inspection the analyst may participate in is a HighRisk Food inspection. High-Risk foods are foods that are susceptible to 

contamination by pathogenic organisms and that are essentially readyto-eat; that is, they will not undergo a sufficient kill step by the preparer. 

Microbiologists are often asked to participate in cheese inspections. 

Some cheeses (primarily soft cheeses) have been linked to foodborne 

outbreaks and illnesses caused by Salmonella, Listeria monocytogenes, 

and Escherichia coli contamination. Consumption of Feta and Mexicanstyle soft cheese has been linked to a high rate of perinatal listeriosis. 
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During the inspection, a microbiologist may be asked to review the 

testing of these pathogens.

3.2. Drug Inspections

There are several different types of drug inspections and each has a different 

focus. For example, a cGMP inspection determines if the laboratory is 

performing analytical testing in accordance with cGMPs. The scope of this type 

of inspection is broad and usually encompasses all product related operations. 

Pre-Approval inspections determine if the laboratory is performing analytical 

testing in accordance with cGMPs, human and animal drug application 

commitments, and the data submitted in the application is verified against the 

raw data. The scope of this type of inspection is narrow and focuses solely on 

operations which impact the drug product mentioned in the application. Post 

Approval Audit inspections provide continuing coverage of approved products.

However, there are areas common to these inspections. As a chemist or 

microbiologist participating in a team inspection, these common areas may be 

used as a starting point during the inspection. 

3.2.1. General Areas (Chemistry and Microbiology Inspections)

The following areas are typically covered during all pharmaceutical inspections 

when applicable. These are considered the backbone of the pharmaceutical 

laboratory inspections. In addition, the United States Pharmacopoeia is useful 

source for information.

3.2.1.1. Accountability of Raw Materials and/or Samples

A. Have an employee, preferably the person who actually works in this 

area and not management, explain the firm’s receiving, sampling, 

assigning samples, and quarantine procedures.

B. Visually examine the receiving area and storage rooms. Determine if 

the room is acceptable for the materials in storage or does the climate 

need to be controlled and if so, how. Examine the temperature control 

records.

C. Review all pertinent Standard Operating Procedures (SOP) and 

compare with actual operations. Review physical records to determine 

compliance with the SOPs for this area. 

3.2.1.2. Testing

A. Examine methods with corresponding product specifications to 

determine acceptability. If a product specification is in question, discuss 

it with the review chemist or review microbiologist for the application. 
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Product specifications are a Center issue and cannot be placed on a 

FDA-483.

B. With the aid of the Investigator, select a product and lot number(s). 

Review all analytical data associated with this product. This includes 

raw material testing, in-process testing, finished product testing, and 

stability testing. Check calculations (or spreadsheets), transcriptions, 

and reviewer’s signatures for errors and discrepancies.

C. Ask for and review the raw data and notebooks associated with each 

test. Compare the raw data to the summary documents.

D. Review method validation records to determine adequacy (See Method 

Validation section for guidance). Determine if the method used in the 

microbiology or chemistry laboratory is the same as the method that 

was validated.

E. Compare all analytical results with product specifications. Determine 

whether raw material or products with non-compliant test results were 

released, retested, or reworked.

F. Examine written procedures for retesting of failed product (for example, 

assay failure or sterility failure) and compare with actual laboratory 

practice. Evaluate if the written procedure is complete and usable (See 

Out of Specification/Product Failure section). 

G. Ask to see all initial positive sterility test results. If a manufacturer of 

aseptically filled products has never found an initial positive sterility 

result, there may be a testing issue.

H. Microbiological testing may include an identification of colonies or 

isolates found during the Total Aerobic Plate Count test or enrichment 

testing. Review these documents.

I. If the method was validated at another site, review the method transfer 

documents to determine if the transfer was a success (see Method 

transfer section for guidance).

J. For ancillary systems, select an audit period for evaluation of water 

system testing and environmental monitoring of controlled areas for 

sterile products.

K. Review bacterial endotoxin, and bioburden testing data for parenterals, 

and any objectionable microorganism testing for non-sterile drugs. The 

amount of testing performed on non-sterile drugs will depend upon the 

product and its intended use. The significance of microorganisms in 

non-sterile pharmaceutical products should be evaluated in terms of the 
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use of the product, the nature of the product, and the potential hazard to 

the user.

L. Media fill, environmental monitoring, sterility test results, and other data 

should be reviewed to assure the absence of slow growing organisms.

M. Determine if raw materials are periodically retested to assure continued 

quality. Review the associated procedures to determine compliance. 

N. Determine if dehydrated media is being used for the preparation of 

media. Good practice includes the periodic challenge of prepared 

media. 

O. Review the methods being used for microorganism incubation to 

determine if they conform to those listed in approved or pending 

applications. Evaluate the time period used for sterility test sample 

incubation.

3.2.1.3. Standards/Controls

A. Visually examine standard/controls storage conditions.

B. Examine how indicator organisms are being stored.

C. Review written procedures to determine how positive and negative 

controls are prepared. Good practice for such testing includes the use 

of known terminally sterilized or irradiated samples as a system control. 

Alternatively, vials or ampoules filled during media fills have also been 

used.

D. Review the standard written procedures and compare with standard 

storage conditions and the use logs for compliance.

E. Determine if the firm uses secondary or in-house standards. Evaluate 

whether the assay to determine potency and purity is complete and 

usable.

F. Determine if the secondary or in-house standards are re-assayed 

periodically. Does the written procedure address how often this reassay occurs? Is there sufficient data to determine if this re-test period 

is valid? Who performs the re-testing?

G. Determine if the primary standard has expired.

H. Determine how often volumetric solutions are standardized. Evaluate if 

this schedule is valid. Determine if commercially purchased standard 

solutions are standardized as well. Keep in mind that commercial 

standards solutions are not primary standards and need to be 

periodically re-standardized.
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I. Review standardization logs or records for completeness and compare 

with the written procedure for compliance.

3.2.1.4. Equipment and Facilities

A. Visually examine analytical equipment for proper maintenance and 

upkeep. Determine if the calibration/qualification status meets the SOP.

B. Obtain a list of analytical equipment that is in use if possible.

C. Review instrument written procedures and compare with maintenance 

and calibration/qualification records for compliance.

D. Determine if the calibration/qualification written procedure is valid. 

Should the instrument be calibrated/qualified daily, weekly, monthly, 

quarterly, yearly? Is there data to support this schedule is followed? 

Does the procedure have specification limits, specific directions, and 

remedial action directions? 

E. Equipment should be evaluated with its intended use in mind. For 

example, dissolution apparatus dedicated to paddles, may not need to 

be calibrated with both paddles and baskets, and an autoclave used for 

a specified temperature range may not have to be calibrated at all 

temperature ranges.

F. For sterile products, the USP states, "The facility for sterility testing 

should be such as to offer no greater a microbial challenge to the 

articles being tested than that of an aseptic processing production 

facility". If possible and feasible, the analyst should actually observe 

how sterility testing is being performed by the laboratory analysts. 

Proper design would, therefore, include a gowning area and passthrough airlock. Environmental monitoring and gowning should be 

equivalent to that used for manufacturing product.

G. Begin the inspection with a review of microbiological analyses being 

conducted and inspect the plates and tubes of media being incubated.

H. Inspect the autoclaves used for the sterilization of media.

I. Inspect ovens used for pyrogenation and washers used for stoppers.

3.2.1.5. Stability

A. Drug products are to remain potent throughout their shelf life. 

Therefore, the firm needs to be able to show that their product still 

meets assay and other specifications throughout its life. In order to do 

this, stability programs are set up and product is tested on a 

predetermined schedule to assure it is still a quality product. This is 
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also required by the cGMPs in 21 CFR 211.166(a). GMPs allow 

accelerated studies to be used to establish a tentative expiration date. 

However, real time stability studies are conducted at defined 

temperatures which reflect normal storage conditions. Stability should 

cover the physical, chemical, and microbial attributes of the drug 

substance. Validated stability indicating analytical procedures are to be 

used (See Stability Indicating Methods and Preservative Effectiveness 

Testing).

B. For real time stability studies, representative samples from a minimum 

of three batches are stored at the labeled temperature (e.g. room, 

refrigerated, frozen) for a period at least as long as the proposed 

expiration date. The recommended testing schedule is quarterly the 

first year, semiannually the second year, and yearly thereafter; yearly 

testing is considered the minimum. Note that the firm’s actual testing 

schedule may vary from this recommendation depending on the 

specifics of the product. The testing schedule will be defined by the 

stability protocol.

C. Once a product is approved, firms are expected to maintain a continuing 

stability program by placing a representative sample from at least one 

batch a year in a room temperature stability program.

D. Temperature, humidity, light, air/oxygen may need to be controlled and 

documented within the specifications set by the stability program 

protocol. The product is stored in the packaging container(s)/closure(s) 

intended for marketing. Product containers are stored in such a way so 

that the product is in contact with as much of the inner surface of the 

container as possible; for example, a bottle of syrup would be laid on its 

side or inverted so that the syrup is in contact with both the bottle and 

the bottle cap. 

E. For Active Pharmaceutical Ingredients, the retest date is the date after 

which a sample of the drug substance should be tested to ensure that 

the material is still potent for use. They are not required to have an 

expiration date.

F. The following steps are taken:

1. Visually examine the products in the stability chambers. Determine 

if the products are in the containers in which they will be marketed. 

Determine if the product is stored properly in the chamber. For 

example, liquids should be stored in both the upright and inverted 

positions.
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2. Evaluate the temperature and humidity controls and determine if 

they will deliver the correct heat and moisture. Are the controls 

standardized with NIST traceable temperatures devices and is there 

sufficient documentation to support this?

3. Review stability written procedures and protocols and determine if 

the firm is in compliance.

4. Review stability testing records and determine whether stability tests 

are performed as scheduled using stability indicating methods (See 

Method Validation section). If scheduled pull dates were missed, 

verify the reasoning for this with related documentation.

5. For sterile products, an evaluation of final product stability at the 

specified expiration date should also be performed.

3.2.1.6. Personnel 

A. Obtain an organization chart for the firm. From this, determine the 

employees involved in lab work.

B. Examine training records for compliance with written procedures.

C. Examine employees’ experience and training records. Review firm's 

procedures for employee qualifications for specific duties and evaluate 

whether employees have been properly qualified to perform the job 

duties you have observed for them.

D. Ensure employees' workloads are doable.

3.2.1.7. Documentation

A. Ensure analytical test, equipment calibrations, and sample 

accountability are thoroughly documented.

B. Ensure analytical records are reviewed and signed off on by authorized 

personnel.

C. Ensure all mark outs, crossovers, and errors are properly explained, 

initialed and dated in accordance with SOPs and GMPs.

3.2.1.8. Standard Operating Procedures (SOPs)/Written Procedures

A. Examine laboratory SOPs and written procedures and evaluate for 

thoroughness and compliance with GMPs.

B. Determine if SOPs are easily found by employees.
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C. Review implementation dates and sign-off dates. Determine if the SOP 

or written procedure that is to be used is actually being used by the 

laboratory analysts.

3.2.1.9. Method Validation, Stability Indicating Methods, and 

Preservative Effectiveness Testing

There are several guidance documents written about chemistry method 

validation. Note that some of these documents are still in draft form. 

Review of these documents is critical in order to gain an understanding 

of what method validation means and what the Agency’s thinking is. 

The United States Pharmacopoeia also describes and defines the 

concept of method validation. 

There are seven common threads throughout these documents: 

accuracy, linearity, range, precision, detection limit, quantitation limit, 

specificity, and ruggedness/robustness. Other factors listed in one or 

more of the documents include recovery, stability of solutions, and 

system suitability. Each factor is clearly explained in the references 

listed. Remember that all of these validation factors are not needed for 

each and every method. The amount of validation will depend on the 

type of method being validated and its intended use.

Table 1 Recommended Validation Characteristics of the 

Various Types of Tests
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Type of Tests / 

Characteristics

ID Testing for 

Impurities

Assay 

Dissolution

(Measurement

 Only), 

Content/Potency

Specific Tests

Quantitative Limit

Accuracy - + - + +4

Precision-Repeatability - + - + +4

Precision-Intermediate 

Precision

- +1 - +1 +4

Specificity +2 + + +5 +4

Detection Limit - -

3 + - -

Quantitation Limit - + - - -

Linearity - + - + -

Range - + - + -

Robustness - + -

3 + +4

NOTE: 

- Signifies that this characteristic is not normally evaluated.

+ Signifies that this characteristic is normally evaluated.

1 In cases where reproducibility has been performed, intermediate precision is 

not needed.

2 Lack of specificity for an analytical procedure may be compensated for by 

the addition of a second analytical procedure.

3 May be needed in some cases.

4 May not be needed in some cases.

5 Lack of specificity for an assay for release may be compensated for by 

impurities testing.

For microbiology methods, it would be virtually impossible to completely 

validate test procedures for every organism that may be objectionable, 

and methods need to be tailored to different types of products. It is 

essential to inactivate preservatives or inhibitory substances present in 

order to provide a better medium for damaged or slow growing cells. 

Other growth parameters include lowering the temperature and 

increasing the incubation time, which may provide a better survival 

condition for damaged or slow-growing cells.
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The selection of the correct neutralizing agents is largely dependent 

upon the preservative, inhibitory substance, and formulation of the 

product under evaluation. If there is growth in the enrichment broth, 

transfer to more selective agar media or an enrichment agar may be 

needed for subsequent identification. The method should optimize the 

recovery of all potential pathogens. There are instances when the 

product may enhance microbial growth and this may need to be 

determined for various assays.

Stability Indicating Methods and Preservative Effectiveness 

Testing

A stability-indicating assay accurately measures the active ingredients, 

without interference from degradation products, process impurities, 

excipients, or other potential impurities. This may be demonstrated by 

performing stress studies, also called forced degradation. Stress 

studies expose the product and/or drug substance to acid and base 

hydrolysis, thermal degradation, photolysis, oxidation etc. The stress 

studies should demonstrate that impurities and degradants from the 

active ingredient and drug product excipients do not interfere with the 

quantitation of the active ingredient. Drug product stress testing (forced 

degradation) may not be needed when the routes of degradation and 

the suitability of the analytical procedures can be determined through 

use of the following:

1. Data from stress testing of drug substance.

2. Reference materials for process impurities and degradants.

3. Data from accelerated and long-term studies on drug substance. 

4. Data from accelerated and long-term studies on drug product.

5. Additional supportive information on the specificity of the analytical 

methods and on degradation pathways of the drug substance are 

found in literature sources.

Method Validation is also addressed in parts 211.160(a), 211.165 (e), 

211.166 (a)(3) and 211.194(a)(2) of the GMPs. It is also addressed in 

various ICH (The International Conference on Harmonization of 

Technical Requirements for Registration of Pharmaceuticals for Human 

Use) documents.

There are four basic microbial tests for finished product and stability 

samples.
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1. Sterility Tests: For products such as sterile intravenous solutions 

and intrathecal injections.

2. Bacterial Endotoxin Tests (Limulus Amebocyte Lysate): Tests for the 

presence of endotoxins in injectable drug products and implanted 

medical devices.

3. Antimicrobial Effectiveness Tests: For products containing 

preservatives to inhibit the growth of microorganisms such as nasal 

and ophthalmic products. 

4. Microbiological Examination of Nonsterile Products (formerly known 

as Microbial Limits Tests): For products that must be free of certain 

microorganisms listed in USP. 

For sterile products, microbial preservative effectiveness testing needs 

to be performed during stability studies. This test is usually later 

replaced by chemical testing. It is important to note that for sterile 

products, container/closure integrity needs to be assessed not only at 

the beginning of the study but also at the end to demonstrate that the 

product remains sterile.

3.2.1.10. Method Transfer

Method transfer occurs when a validated method is transferred from one 

group, site, or company to another. There needs to be a Method Transfer 

protocol/plan/procedure in place. This protocol outlines the testing to occur, the 

roles of the two laboratories, and defines the acceptable values for the transfer 

to be accepted. During the inspection, the data from the transfer should be 

reviewed and compared to the protocol to determine if the data meets the 

acceptance criteria. Typical instances when method transfer occurs are from 

the Research and Development (R&D) laboratory to the Quality Control (QC) 

laboratory, Site A to Site B when a product line is moved, and Company X to 

Company Y when a product is purchased by another company.

3.2.1.11. Out of Specification (OOS) Results

During the course of analytical testing, there will be times when results are 

generated that do NOT meet product specifications. It is imperative that the 

firm has a procedure in place to handle these occurrences. During the 

inspection, an analyst needs to obtain a list of all batches which had an OOS 

result as well as a list of all failure investigations performed. It is important that 

when reviewing data, raw data is included in the review. Often passing results 

are obtained by averaging a passing result with an OOS result. 

FDA regulations require that an investigation be conducted whenever an OOS 

test result is obtained. The purpose of the investigation is to determine the 
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cause of the OOS. Even if a batch is rejected based on an OOS result, the 

investigation is needed to determine if the result is associated with other 

batches of the same drug product or other products. Batch rejection does not 

negate the need to perform the investigation. The regulations require that a 

written record of the investigation be made including the conclusions of the 

investigation and follow-up (21 CFR 211.192).

The FDA has published “Guidance for Industry Investigating Out-ofSpecification (OOS) Test Results for Pharmaceutical Production” to assist 

industry and FDA investigators and analysts when reviewing OOS 

investigations. The concepts mentioned in the guidance document apply to 

laboratory testing during the manufacture of active pharmaceutical ingredients, 

excipients, and other components and the testing of finished products to the 

extent that current good manufacturing practice (CGMP) regulations apply (21 

CFR parts 210 and 211). The guidance discusses how to investigate suspect 

or OOS test results, including responsibilities of laboratory personnel, 

laboratory phase of the investigation, additional testing that may be needed, 

when to expand the investigation outside the laboratory, and the final 

evaluation of all test results.

3.3. Team Inspections versus Solo Contract Laboratory inspections

A. Analysts that participate in inspections may be part of an Investigational 

Team consisting of Investigator(s) and possibly other analysts 

depending on the firm and focus of the inspection. 

B. As a team member, the analyst will be expected to follow the 

Investigations Operations Manual (IOM) and communicate with the lead 

investigator. The IOM can be found at 

http://www.fda.gov/ICECI/Inspections/IOM/default.htm. The electronic 

copy is the official version and should be referenced prior to performing 

an inspection. 

C. The lead investigator is ultimately responsible for the inspection. 

However, an analyst needs to make sure that he or she is also aware of 

the objectionable conditions that the other team members are finding. 

Communication between team members is important. Manufacturing 

cGMP violations may also result in laboratory violations. The analyst 

will be responsible for writing their part of the FDA-483 Observations, 

but the lead investigator may change the wording to follow his/her style. 

In many instances, it is a give and take situation. When the investigator 

is rewording the analyst’s observations, focus on whether the intent and 

meaning of the observation is the same. If the rewording changes the 

meaning or intent, clearly explain this to the investigator and works 
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together to write the observation so all team members understand the 

objectionable condition. 

D. If the analyst is acting as the lead investigator, the analyst should 

familiarize him or herself with the IOM. The analyst will need to issue 

the FDA-482 Notice of Inspection upon entering the inspection site. 

Issuance of the FDA-483 is clearly explained in the IOM. While 

performing a "solo" inspection, extremely violative conditions may be 

found. Consult with the local district office management to determine 

the course of action. Documentary samples and/or physical samples 

may need to be collected and an affidavit and/or receipt for the sample 

may need to be issued. Some districts may choose to send an 

investigator out for this part of the inspection or the analyst may be 

asked to do this on their own. If the analyst is to proceed alone, he or 

she should consult the IOM for the proper procedure and paperwork, as 

well as, with the local investigation staff, determine the best course of 

action. 

E. For analysts participating in inspections, the following sections in the 

IOM are extremely helpful:

1. CHAPTER 5 - ESTABLISHMENT INSPECTION 

2. Subchapter 5.1 Inspection Information

3. Subchapter 5.2 Inspection Procedures

4. Subchapter 5.3 Evidence Development

5. Subchapter 5.4 Food

6. Subchapter 5.5 Drugs

7. Subchapter 5.6 Devices

8. Subchapter 5.7 Biologics

9. Subchapter 5.8 Tobacco Products

10.Subchapter 5.9 Veterinary Medicine

11.Subchapter 5.10 Reporting

These subchapters identify the basics of an inspection. In the case of 

Drug Inspections, the IOM outlines the general areas covered during 

inspections. 

4. Establishment Inspection Reports

A. Upon completion of an inspection, an Establishment Inspection Report 

(EIR) is written which details inspectional findings. Because analysts 
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may work independently of investigators during a team inspection, the 

analyst will submit a written report which is appended to the 

investigator's report. Excellent communication between the analyst and 

the investigator is the key during this type of inspection. There are some 

situations when the analyst and investigator are working so closely 

together that a separate report may not be needed, for example, the 

inspection of a contract laboratory. In this case, the analyst and 

investigator work out the details of how the report is to be written. All 

reports are prepared as stand-alone documents outside of FACTS. The 

establishment Inspection Report (EIR) is to: 

1. Be factual, objective, and free of unsupportable conclusions.

2. Be concise while covering all aspects of the inspection.

3. Not include opinions about administrative or regulatory follow-up.

4. Be written in the first person using the active voice.

5. Be signed by all FDA and commissioned personnel participating in 

the inspection. See IOM section 5.1.2.5.1 when more than one FDA 

or commissioned person participated in the inspection.

B. For an inspection that does not fall under the auspices of eNSpect, the 

analyst portion may consist of several sections depending on the scope 

and the length of the inspection. The IOM gives detailed guidance about 

the content of the EIR under section 5.10.4 – Narrative Report and 

5.5.8- Drug Inspection Reports.

1. Analytical Narrative

2. Objectionable Conditions

3. Discussion with Management

4. Exhibits

The narrative section details what was covered during the inspection 

(e.g. Samples/Batch review, Testing/Laboratory Operations, Laboratory 

Equipment Calibration/Qualification, 

Standards/Controls/Media/Reagents, Method Validation, OOS/Failure 

Investigations etc.). Depending on the scope, length of the inspection 

and significance of the finding, the analyst and the investigator may 

choose to include subheadings to clarify the report. The Objectionable 

findings/conditions section includes a detailed account of each 

objectionable condition (verbal and/or listed on the FDA 483) including a 

clear description of each, its impact on the product, batches or lots 

involved, and any relationship to other products or processes. Identify 
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the responsible party for each violation. Report the discussion of all 

objectionable conditions from the daily inspection review and the 

discussion with management at the conclusion of the inspection. The 

"Discussion with Management" section of the report records

management's response to objectionable conditions which are 

discussed during the exit interview. It also includes the names and titles 

of each person at exit interview. The investigator and analyst need to 

coordinate who writes this section and how it is written.

5. FDA-483 Objectionable Conditions and Practices

A. Once an inspection is completed and before leaving the firm, an FDA483 may be issued to the most responsible person at the site inspected. 

The FDA-483 itemizes all significant deviations from cGMPs. This may 

be prepared using eNSpect if applicable. If this is the case, please refer 

to the eNSpect section for additional guidance. 

B. When writing 483s as an analyst, observations should be:

1. Significant and correlate to regulated products or process inspected.

2. Directly linked to a cGMP regulation for inspections using eNSpect.

3. Clear, accurate, and complete.

4. Product names and lot numbers should be listed in the observation

5. Listed in the order of significance.

6. Legible if hand written.

7. Related to the inspection. For example, failure to adhere to 

application commitments is an FDA-483 observation. However, 

product specifications are not a FDA-483 observation; and they 

should be discussed with the application Reviewer and addressed 

as a headquarters issue rather than a field issue.

6. eNSpect

A. The eNSpect application is comprised of two components:

1. eNSpect Web – a web-based application used mainly by those with 

a Supervisory role to create new inspection assignments, view 

assignments, and endorse the inspection.

2. eNSpect Field Client – a desktop application loaded on the 

Investigator’s laptop that can be used online or offline. The bulk of 

the Investigator’s work is performed on the ENSPECT Field Client.
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B. The analyst should obtain access to eNSpect and ensure the inspection 

is associated with their laboratory in FACTS. This will ensure the 

analyst and the laboratory will receive time for the analysts’ work 

conducted on the inspection.

6.1. Operating as the Lead Investigator

Lead Investigators must follow procedures detailed within the eNSpect 

guidance document found under ORA Applications 

(http://inside.fda.gov:9003/it/Applications/ORAApplications/default.htm).

6.2. Operating as Part of a Team Inspection

A. Specific roles are assigned for Inspectional Teams: Team Leader aka 

Lead and team members aka anyone other than the Lead participating 

in the inspection. Duties will be determined based on these roles.

B. Teams can only be created once a Lead Investigator is assigned. A 

Supervisor can make team changes until the assignment is placed into 

progress within eNSpect. Once the assignment is changed to in 

progress, only the Lead Investigator can make team changes. Once 

the Lead creates the team and synchronizes with FDA network, each 

team member will receive DNS notification.

C. This is needed in order for the analyst’s name and title to appear in the 

signature block area of both the FDA-483 and the EIR, regardless of 

whether or not the analyst has a laptop. 

D. The analyst will find that communications between all members of the 

inspectional team are critical when using eNSpect, especially with 

respect to developing the FDA-483 and writing the EIR.

6.3. Writing FDA-483 Observations in eNSpect

A. Once it has been established that eNSpect is going to be used on an 

inspection, the analyst is to write observations in eNSpect format 

regardless of whether the analyst has the application on their laptop. 

Each team member who has the eNSpect application can 

independently work on the FDA-483 on his or her own laptop. 

Independent team member observations shall be synchronized either at 

the end of each day or as determined by the Lead, thereby pushing 

their observations up to the FDA server. After all team members 

synchronize, the Lead will synchronize which brings all the observations 

into the Lead’s computer. The team members can then synchronize 

again, which will download the latest version of the assignment showing 

all team members’ observations. 
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B. Once the Lead completes their synchronization, this becomes the 

original 483 and is maintained on their computer. The Lead has the 

ability to edit all team members’ work, while team members can only 

edit their own work. Team members working independently may 

duplicate citations; however, the Lead will determine final citations prior 

to completion of the 483. The Lead will Print and Issue Final Form 483. 

All team members present at time of issuance must electronically sign 

the 483 using PIV card.

C. Please refer to eNSpect User Guide for details. If the analyst has 

difficulty identifying which citation(s) have been violated, ask the Lead 

Investigator for assistance. Analyst may be referred to a Supervisory 

Investigator or the Compliance Branch for assistance as well.

D. If the analyst performs several inspections in a year, printing out the 

main or often used citations may be an advantage. It allows the analyst 

to read the citation on paper and discuss it with the investigator, 

whereas doing all on the computer can be more cumbersome at times.

6.4. Writing the Establishment Inspection Report in eNSpect 

A. Before the analyst begins writing the Establishment Inspection Report in 

eNSpect, the FDA-483 is signed and issued. All team members may 

work on the EIR independently; however, synchronization is required for 

information to be passed to the Lead. Unlike the 483, team members 

can only view their work and the Lead’s – they will not see other team 

members’ work. 

B. Team members can add attachments or exhibits; however, everyone 

should follow the same naming convention for consistency and should 

be discussed during the inspection. Once the EIR is in its final form, the 

Lead will finalize and synchronize. The Lead will then notify each team 

member independently for electronic signature. Once all signatures are 

obtained, the Lead will complete the Coverage and Conclusions page 

and the Endorsement page. 

C. Please refer to the eNSpect User Guide for details. 

D. Questions regarding eNSpect are best directed to the Lead Investigator.

7. Computerized Systems and Electronic Records

A. Electronic records are records in electronic form that are created, 

modified, maintained, archived, retrieved, or transmitted under any 

records requirements set forth in agency regulations. This part also 

applies to electronic records submitted to the agency under 
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requirements of the Federal Food, Drug, and Cosmetic Act and the 

Public Health Service Act, even if such records are not identified in 

agency regulations. However, this part does not apply to paper records 

that are, or have been, transmitted by electronic means.

B. Generally, analytical electronic records are generated on computerized 

systems, including, but not limited to chem-stations associated with 

analytical equipment such as HPLCs, GCs, FTIRs, and UVs. 

Computerized systems may also be connected to balances and other 

equipment where data is obtained. Computerized laboratory equipment 

should be evaluated during the inspection to determine if there is a data 

trail for the deletion and/or modification of data. The audit trail should 

have a time and date stamp and indicate what was modified and what 

the modifications were. If the software was written by the firm’s 

technical support group, review the validation records and the 

challenges the firm performed. Determine if there have been any 

changes to the system or software since validation. If so, was a 

revalidation performed?

C. Electronic Records and Signatures regulations apply to any record in 

electronic form that was created, modified, maintained, archived, 

retrieved, or transmitted under agency records requirements. These 

regulations also apply to any electronic record submitted to the agency.

D. References:

1. Code of Federal Regulations (CFR) Title 21 → Chapter I → 

Subchapter A → Part 11 Electronic Records/Electronic Signatures

8. Helpful References Pages on the Internet or Intranet

A. ORA Inspection References

B. ORA Inspections, Compliance, Enforcement, and Criminal 

Investigations (ICECI) Inspection References

C. ORA Investigations Operations Manual (IOM)

D. Electronic Code of Federal Regulations Title 21 Food and Drugs

E. Inspections, Compliance, Enforcement, and Criminal Investigations 

(CDER) Inspection Guides

F. Animal and Veterinary (CVM) Guidance for Industry 

G. CVM Bovine Spongiform Encephalopathy (BSE) Guidances

H. CFSAN Food Guidance Documents 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 5

Document Number:

III-05

Revision #: 02

Revision Date:

08/13/2019

Title: 

Analysts on Inspection Page 28 of 29

For the most current and official copy, check QMiS.

I. Vaccines, Blood & Biologics (CBER) Guidance, Compliance & 

Regulatory Information (Biologics)

J. CDRH Guidance Documents (Medical Devices and Radiation-Emitting 

Products)

K. Medical Devices (CDRH) Quality System (QS) Regulation/Medical 

Device Good Manufacturing Practices

L. The International Council for Harmonisation of Technical Requirements 

for Pharmaceuticals for Human Use (ICH) Official Website

M. Veterinary International Conference on Harmonization (VICH) Guidance 

Documents

N. Regulatory Information 

O. Product Code Builder

P. eNSpect Guidance

http://inside.fda.gov:9003/it/Applications/ORAApplications/default.htm.

9. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 06/06/08 LMEB LMEB

1.3 R 02/02/10 LMEB LMEB

1.4 R 02/24/11 LMEB LMEB

1.5 R 01/30/13 LMEB LMEB

02 R 08/13/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

10. Change History

Revision 

# Change
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 5

Document Number:

III-05

Revision #: 02

Revision Date:

08/13/2019

Title: 

Analysts on Inspection Page 29 of 29

For the most current and official copy, check QMiS.

1.2

5.1, second website updated

5.3.3 IOM subchapter and links updated

5.6.2 section updated

5.8 Reference 2, 6, and 12 updated

1.3

5.2.1 – added bullet to list; deleted fourth sentence in paragraph 5

5.2.3 – revised last paragraph

5.3.1 – revised paragraph 7

5.3.2.1 – added last sentence to paragraph 1

5.4 – updated web link

5.7 – deleted last two bullets under References

5.8 – updated web links

Footer – updated web link

1.4 5.3.3 – updated web link for the IOM

5.8 – removed CGMP Notes web link

1.5 Header – Division of Field Science changed to Office of Regulatory Science

02 Added procedures for eNSpect and removed content on TurboEIR. Clarified 

policy/procedures across the document.

11. Attachments

None