Sections in This Document

1.

2.

3.

4.

Objective...................................................................................................................................1

Introduction ...............................................................................................................................2

Sampling...................................................................................................................................3

Information about the Private Laboratories ...............................................................................3

4.1.

4.2.

Private Laboratory Analysts ...........................................................................................4

Review of Analytical Packages ......................................................................................5

5. Audit Samples...........................................................................................................................9

5.1.

5.2.

5.3.

5.4.

5.5.

Private Laboratory Observations ..................................................................................10

Analytical Packages .....................................................................................................10

Detention without Physical Examination (DWPE)/MOU's.............................................11

Sampling ......................................................................................................................11

Evaluation of Audit Sample Result ...............................................................................11

6.

7.

8.

9.

10.

11.

12.

On-site Assessment Visits ......................................................................................................11

Consultations ..........................................................................................................................12

Meetings ................................................................................................................................. 12

Continuing Problems...............................................................................................................13

Time Reporting .......................................................................................................................13

Requests for Referrals ............................................................................................................13

LAAF Program ........................................................................................................................13

Document History ...................................................................................................................14

Change History .......................................................................................................................14

Attachments............................................................................................................................15

Attachment A - Example of Collection Report.........................................................................16

Attachment B - Example of Analyst Background and Training Record ...................................17

Attachment C - Example of Analytical Report.........................................................................18

Attachment D - Private Laboratory Package Review Guide....................................................19

1. Objective

The objective of this section is to establish a uniform, systematic, and effective approach 

to ensuring that private laboratories performing analyses on FDA-regulated, commodities 

submit scientifically sound data. The FDA Food Safety Modernization Act (FSMA) final 

rule on Laboratory Accreditation for Analyses of Foods (LAAF) establishes an

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 1 of 20
accreditation program for the analyses of foods in certain circumstances. The LAAF 

program is currently in the implementation phase; once implemented this document will 

be updated to include LAAF program requirements.

Introduction

Importers are responsible for ensuring that the articles they import comply with all 

provisions of the Federal Food, Drug and Cosmetic Act. In some instances, products 

may be detained as soon as they are offered for entry into the United States. This 

procedure, detention without physical examination (DWPE), is based on history or other 

information indicating that the product may be out of compliance with federal laws and 

regulations. Products or shippers that have met the criteria for DWPE are identified on

Import Alerts, which disseminate information to FDA personnel about problems and 

violative trends. (Import Alerts (fda.gov)

FDA has the obligation of evaluating the analytical data submitted by private laboratories 

to determine whether import entries comply with the Act and can be released into 

commerce. It is essential, that the data provided is technically valid, has been obtained 

using sound methods of sampling and analysis, and has recognized quality assurance 

measures applied.

While this document is written in reference to private laboratories, the owner or 

consignee is ultimately responsible for compliance with applicable laws and regulations. 

If a private laboratory does not provide acceptable evidence and documentation to 

support the credibility of the analysis, the owner/consignee bears the responsibility and 

consequences of the inadequacy.

Although FDA has legal authority over regulated imported products, it does not have 

such direct authority over the private laboratories. (Note: This applies to private 

laboratories that analyze imported products. Laboratories that test domestic products 

may be subject to different regulations. For example, private laboratories used by 

pharmaceutical firms are to register as manufacturers with the agency and are subject to 

GMPs. Such laboratories are not addressed in this guidance.) The agency can make 

decisions on a lot-by-lot basis regarding the entries submitted for importation. The 

acceptability of the work performed by the private laboratory is an important element in 

this decision.

It should be noted that because circumstances vary among division offices and 

laboratories, there is no single set of procedures that can be prescribed for the entire 

field. For example, divisions that are physically near their servicing laboratory can more 

easily call on them to perform such services as on-site assessment visits than divisions 

that are not. For this reason, this document recommends suggested procedures that 

divisions and field laboratories may adapt to their needs.

2.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 2 of 20
3. Sampling

A. Sampling for analysis is to represent the lot. If, in the judgment of the 

reviewing office, the method of collection does not result in a representative 

sample, the analytical package should be rejected. Sampling should be 

performed in conformance with FDA-recommended sampling procedures 

and Compliance Programs.

Investigations Operations Manual | FDA

Manual of Compliance Policy Guides | FDA

To maintain chain of custody, the sampler must properly collect, identify, 

and maintain samples from the time they are collected until they are 

delivered to the private laboratory. The sampler should:

B.

1.

2.

Verify the location and identity of the lot to be sampled;

Collect samples following FDA sampling guidelines or other equivalent, 

established guidelines;

Ensure the integrity of the sample (avoid contamination with use of 

aseptic technique, maintain storage temperature, and utilize additional 

measures as needed to ensure the integrity of the sample);

Identify the containers from which samples are collected with the FDA 

sample number and/or the U.S. Customs Service entry number;

Prepare and ship the sample using precaution to prevent contamination 

and maintain sample integrity; and

Complete a collection report for each sample collected which includes 

sample collection methods, sample preparation techniques, lot size and 

identification number, sample size, identity of the sample collector, 

statement from the collector of any observations about the lot, 

containers, etc., and description of chain of custody of the sample.

3.

4.

5.

6.

C. If the method of collection does not result in a representative sample, the 

analytical package is considered unacceptable.

See Attachment A for an example collection report.

4. Information about the Private Laboratories

A. For the sake of efficiency and historical perspective, the field components 

that deal with private laboratories should retain databases or files on each 

one from which it receives analytical packages. Examples of useful 

information for these files are described in the following list.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 3 of 20
1. The name, address, and telephone number of the laboratory and the 

name and title of key officers or contacts.

Information on the background, experience, and training of the analysts. 

(See below for additional guidance.)

Types of analyses performed by the private laboratory on regulated 

commodities. Such a list indicates the scope of the laboratory’s work.

Equipment used for conducting the analyses. This aids in determining 

whether laboratory equipment is present to perform the routine 

methods.

Information on the laboratory’s internal quality assurance program. This 

information is useful in evaluating the validity of analytical data 

generated by the laboratory, although it in no way lessens the need for 

the QA data for the analysis being performed to be submitted as part of 

the analytical package.

Reports of FDA’s prior contacts with the private laboratory, including 

previously reviewed packages, reports of on-site assessment visits, 

correspondence, and summaries of telephone conversations and 

meetings.

2.

3.

4.

5.

6.

B. If the reviewing office cannot obtain the information it needs to perform the 

review of the scientific analytical data generated by the private laboratory, 

either directly from the laboratory or through the importer/ broker, the 

analytical packages received from the laboratory will be considered 

incomplete. Without credible information, there is no way of assuring the 

scientific integrity of the data being submitted.

4.1. Private Laboratory Analysts

A. Information on the background, training, and experience of the analysts 

bears further discussion. Just as a laboratory is to have the appropriate 

equipment to do the work, so too it is essential to have properly trained or 

experienced staff.

Often, the analyst’s curriculum vita (CV) is attached to the package. If it is 

not, and the reviewing FDA component doesn’t have a prior record in lab 

file, then the laboratory should be contacted and asked to provide it.

Attachment B is a suggested format for the Analyst CV or 

Training/Background. It may be shared with the private laboratory.

The CV for each person who participated in the analysis must be submitted 

or be available on file as needed by each reviewing district or laboratory. It 

is not sufficient to have only the laboratory director’s CV, unless he or she

B.

C.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 4 of 20
was the only one performing the work. A private laboratory director or 

supervisor may sign a package; however, the analyst signatures must also 

be included.

On occasion, a private laboratory will contract its work out to a second 

laboratory. The package should be shown as being done by the laboratory 

that performed the analysis, not the laboratory that contracted it out. If the 

paperwork does not make it clear that this was done, the contracting 

laboratory should be contacted and asked to submit a CV for that analyst if 

one was not provided.

The CV provides documentation of the analyst’s ability to perform the 

analysis performed. The CV should provide evidence of training and 

experience directly related to the analysis performed by the analyst in 

question. For example, documentation of an analyst’s ability in pesticide 

analysis is not sufficient for a subsequent submission of a sensory analysis.

Once the CV is received, it is reviewed for adequacy. While there are no 

requirements for the background of the private laboratory analyst, there 

should be evidence that they have the education, training, or experience to 

perform the work. Often, the analysts do not have a college degree and 

may have received their training on the job. This would not in itself 

disqualify them from being able to perform the analysis. There should, 

however, be documentation that they have had preparation for each kind of 

analysis they submit.

If, as recommended, FDA personnel review the analytical packages, it is 

further suggested that the CVs be reviewed by a laboratory supervisor, 

manager, or senior analyst. The CV should be retained for filing. If the CV 

is not sufficient, this information should be communicated with the private 

laboratory and explain what additional information is needed. If the 

laboratory does not provide the information, then the package should be 

evaluated as unacceptable.

D.

E.

F.

G.

4.2. Review of Analytical Packages

A. The analytical package consists of the collection report, the private 

laboratory worksheet, and the laboratory report form (see Attachment C for 

example of a report) Since the worksheet is the most important part of the 

package, a thorough technical review of the work performed is needed. 

Qualified FDA personnel who work in the area of analysis under review are 

best suited to perform this review. They are most familiar with current 

methods, acceptable practices, and quality controls that are needed. 

Therefore, it is strongly recommended that whenever possible, these 

packages be sent to the laboratory for review.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 5 of 20
B. A review should begin with the Import Alert. This will provide the reason for 

detention. The analysis performed should correspond to the problem area 

identified in the Import Alert. For example, if the reason for the Import Alert 

is the possible presence of a particular pathogen or pesticide, then an 

analysis for the detection of that analyte is to be performed.

Once the analysis has been established, the reviewer should look at the 

collection report and determine whether the sample size, type, and method 

of collection were consistent with resolving the problem. Next, the 

availability of a CV for the analysts should be ascertained, as described in 

the section above.

In some senses, then, the private laboratories are doing agency work. They 

are analyzing regulated commodities and they are to do so with the same 

care and control with which FDA does its work. This should be kept in mind 

when reviewing the packages. While the worksheet format used by the 

private laboratory may differ from FDA practices, all the essential elements 

that are needed for FDA analyses are to be documented in the package. It 

would be inconveniently lengthy to itemize each of the elements for all 

types of analysis, but in general, this is the standard that the packages are 

to meet.

The following documentation should be provided for each analytical 

package submitted to FDA, as applicable. This information helps establish 

that valid analytical techniques and quality assurance practices were used.

C.

D.

E.

1. Identity of the analysts, signatures, and dates on which the work was 

performed.

Analytical methods used, method verifications, references, and any 

modifications, in-house validations of the methods.

Signed worksheets containing instrument calibration data, readings and 

conditions, calculations, quality controls applied, blanks, fortified 

samples, sample weights and measurements, dilutions, matrix clean-up 

procedures, and any other analytical data.

Calculations presented in a logical manner. Reference to 

chromatograms and spectra are made in a clear order.

Source and purity of reference standards, storage conditions, and 

procedure for preparation.

Analytical documentation such as chromatograms, charts, graphs, 

observations, and photographs of thin layer chromatographic plates.

A copy of the label from the immediate container and any additional 

labeling needed to evaluate the product.

2.

3.

4.

5.

6.

7.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 6 of 20
F. Attachment D is a private laboratory package review guide that may be 

used as an aid in evaluating the analytical worksheets.

Unacceptable versus Violative Results. The purpose of performing the 

package reviews is to evaluate whether packages are clear, complete, and 

accurate records of the analytical work that was performed. This review is 

primarily performed on packages with non-actionable results. It should be 

noted, however, that the evaluation of the acceptability of a package is 

separate from its actionable or non-actionable status. A violative package 

may be acceptable, and a non-actionable package may be unacceptable. 

The validity of a non-actionable package is important because it could 

result in the release and distribution of harmful product that otherwise 

would have been detected if the correct method was used or the proper 

laboratory controls followed.

Packages with unacceptable results. The following description of packages 

that may be unacceptable is meant as guidance only. The list is neither allinclusive nor exclusive. For example, there may be something that makes a 

package unacceptable although it is not on the list. The reviewer’s 

judgment, in consultation with his or her supervisor is extremely important 

in this process.

Many of the items that are not on the list were left off because they can and 

should be worked out by calling the private laboratory to discuss them. An 

example of this is uncertainty about the identity of the sample. If there is 

disagreement between the collection records and the analytical worksheet, 

this is resolved with the private laboratory before going further. There are 

occasions when the private laboratory is contacted because the packages 

are missing essential information, such as legible reports or 

chromatograms.

G.

H.

1. Incorrect results for the particular type of sample or unusual results. An 

example of this is questionable biochemical reactions obtained during 

microbiological testing.

Incorrect amount of sample used for analysis. For example, a method 

calls for 100g of sample and the private laboratory uses 500g without 

adjusting the initial extraction volume or the other dilutions. Methods are 

tested and validated at particular levels and exceeding those levels may 

invalidate the results.

Incorrect number of subsamples analyzed. The number of subsamples 

examined is not consistent or does not follow guidelines. For example, a 

method may call for the examination of 15 subsamples for Salmonella 

and the private laboratory only tested 10.

2.

3.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 7 of 20
4. Failure to determine values for each part of surgical forceps. Both sides 

of forceps should be tested because there may be a difference (per 

CDRH). LIB #3750 directs that for separate forged parts, each part 

should be tested.

Omission of significant analytical data. For example, biochemical 

reactions are missing, such as the recording of TSI and LIA reactions 

for Salmonella. Records of use of controls are absent.

Omission of quality assurance numbers. For example, omission of 

several microbiological quality assurance numbers, or a single omission 

of a quality assurance number for an important component (such as 

manufacturer's lot number and expiration date for a microbiological test 

kit).

Method modifications without indication of validation.

5.

6.

7.

I. When a package is found to be unacceptable, the compliance officer is 

responsible for communicating the findings to the importer and private 

laboratory. They may ask the ORA laboratory for assistance in discussing 

technical issues.

Packages that are acceptable with comments. A package may be 

acceptable but may contain flaws or weaknesses. For instance, the 

workflow may be difficult to follow, or the worksheets may have numerous 

cross-outs. Sometimes, the reviewer has suggestions that may make future 

packages stronger or clearer. In these cases, the reviewer should evaluate 

the package as being acceptable with comments. These comments are 

typically communicated to the laboratory via email by the Compliance 

Officer or Program Coordinator. If a phone call or meeting is held with the 

laboratory, the reviewer may be asked to participate. A memo of the 

telephone conversation should be written to document the discussion and 

be given to the compliance officer as well as copied to the file.

Packages with violative results. In general, violative packages should not 

be sent to the laboratory for review since the importer is not asking the 

agency’s permission to admit the entry (at least, not prior to reconditioning). 

This, however, is subject to local practice in the divisions.

Packages with borderline results. If a package is reviewed that has 

borderline results (for example, if 1 ppm of methyl mercury in swordfish is 

violative, and the analytical package reports 0.9 ppm methyl mercury) note 

this in the review of the package. This does not make the package 

unacceptable but is simply information for the compliance officer.

Analyses on multiple sub-portions of one entry. Some entries have 

separate analyses performed on smaller sub-portions of the entry. These

J.

K.

L.

M.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 8 of 20
sub-portions may correspond to Customs or FDA line numbers, date codes 

or sizes, for example. This is often true for seafood samples. It may also 

occur under other circumstances, for example, when ethylene oxide 

sterilization and subsequent analysis is performed on separate portions of 

a spice entry. At other times, the reverse situation occurs, that is, one 

analysis is submitted for several sub-portions. In such cases, each analysis 

submitted should be evaluated.

Packages from foreign laboratories. These are reviewed using the same 

criteria as for domestic private laboratories. When a Memorandum of 

Understanding (MOU) exists, packages should be in accord with the MOU. 

If the division office has information (such as audit sample results) that the 

products are violative, the entry in question should be detained, despite 

certification, and the Office of Import Operations (OIO) and Office of 

Regulatory Science (ORS) should be notified. OIO and ORS will work with 

the International Affairs staff and the Center offices to resolve the problem.

Timeliness. Since an entry cannot be released until the private laboratory 

analysis has been reviewed, the agency is under the same obligation to 

complete its review in a timely manner as it is for the products it analyzes. 

The laboratories should track receipt of analytical packages and the dates 

the results are sent out. It is suggested that laboratories complete these 

reviews and report back to the compliance officer within two working days 

of receipt of the analytical packages. Packages documenting analysis of 

fresh, perishable products should be completed within one day. The need 

for additional information, an analyst’s CV for example, “re-sets” the clock 

to the date of receipt of the information.

Reporting the results. ORA laboratories typically report their results to 

home divisions. In this case, however, there are as many as three 

possibilities for what may be called the home division. The private 

laboratory may be located in one division, the importer in a second, and the 

entry may be made in a third. For the purposes of this document, the 

division where the entry is being made is considered to be the home 

division. This is the primary location to which results should be reported.

The home division compliance officer is responsible for informing the 

importer and private lab.

N.

O.

P.

5. Audit Samples

At times, audit samples are collected, preferably from the same container as the original 

sample collected by the importer, sampling service, or private laboratory. They are tested 

by an ORA laboratory to verify the analytical results that purport the product to comply 

with the FD&C Act. The package reviewer may request collection of an audit sample.

Because resources are limited, not every request will necessarily result in a collection.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 9 of 20
The factors below are suggested criteria for the recommendation for collection of audit 

samples. Collection should be made when substantial and significant incidences are 

observed in the following analytical areas.

5.1. Private Laboratory Observations

A. If analytical problems are found during an assessment visit of a private 

laboratory made by any division. Samples should be related to the types of 

analytical problems observed.

If this is the first submission of a private laboratory or analyst for a 

particular type of analysis.

In general, our goal is to collect audit samples for 10% of the work 

performed by a private laboratory, to be increased if findings warrant. This 

includes both samples collected due to factors on this list and random 

samples.

B.

C.

5.2. Analytical Packages

A. For analytical packages that are unacceptable upon initial review. However, 

no audit sample should be collected until corrections have been made so 

that the package is found to be acceptable. For example, if a package is 

incomplete, no audit samples should be collected until the missing 

information has been supplied and reviewed.

For types of analyses and commodities for which reports with errors, 

technical problems, or missing data have been submitted during the past 

year.

For reports with abnormal or unexpected results or data—such as reports 

indicating no growth of microorganisms or negative filth or decomposition 

results. These can be in a product, shipper, or country combination that 

often has these elements, or exceptionally "clean" chromatograms for 

products that usually exhibit product peaks.

For multiple borderline analytical results of a given type, or other potentially 

suspect findings associated with borderline results. For example:

B.

C.

D.

1.

2.

3.

4.

5.

6.

0.9 ppm methyl mercury in swordfish; 

11.5% chromium in surgical instruments; 

1 of 18 cans of tuna for decomposition;

3 of 18 subsamples of shrimp for decomposition; 

large numbers of class 2 shrimp;

excessive filth in one subsample but none in other subsamples;

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 10 of 20
7. pesticide residues close to the tolerance levels; or

8. aflatoxin close to the tolerance levels.

Detention without Physical Examination (DWPE)/MOU's

A. It is recommended that at least one audit sample should be collected and 

analyzed before removing a product, shipper, or country off DWPE.

B. As called for by MOUs or compliance programs and assignments.

Sampling

A. When there are past findings of erroneous, incomplete, or suspect 

sampling procedures by the private laboratory, importer, or third-party 

sampler.

B. For samples collected by the importer rather than by the private laboratory 

or an independent sampler.

Evaluation of Audit Sample Result

If the ORA laboratory finds an audit sample violative for an entry that the private 

laboratory had previously found in compliance, it can not necessarily be concluded 

that the discrepancy is due to a problem on the part of the private laboratory.

Possibly the analyte was not homogeneously distributed, or the sampling was not 

done correctly (for which the private laboratory would not be responsible unless it 

had performed the sample collection). Each case is evaluated individually. If it 

cannot be determined where the problem lies, then additional audit samples or an 

on-site assessment visit may be warranted.

5.3.

5.4.

5.5.

6. On-site Assessment Visits

A. At times, the agency visits the laboratory to ascertain that it has the 

capability or capacity to perform the analyses. Often, these visits are 

precipitated by an accumulation of elements that may call the laboratory’s 

capabilities into question. Differences from FDA’s results on audit samples, 

repeated borderline or questionable results, or multiple unacceptable 

packages are typical examples. Alternatively, visits may be made simply for 

the laboratory or division to become familiar with the private laboratories in 

their vicinity.

The on-site visit provides the opportunity to observe that equipment, 

reagents, and standards needed to conduct the proposed analyses are 

present and in good order; to review the adequacy of the laboratory’s 

quality assurance and record-keeping programs; and to observe the 

techniques and practices of the analysts. Site visits should ideally occur 

when the analyses at issue can be observed. These information-gathering 

activities round out the picture of the laboratory’s capabilities.

B.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 11 of 20
C. On-site assessment visits are not inspections. They differ in many 

significant ways. They are voluntary; the laboratory may decline to 

participate. Neither a Notice of Inspection (Form FDA 482) nor Inspectional 

Observations (Form FDA 483) is presented. The date of the visit is by 

appointment. If the visit is being made in connection with a particular 

package, it should be scheduled in advance with the private laboratory 

through the importer or broker whose entry is under review.

A team of inspectional and laboratory personnel may conduct the 

assessment visits, or they may be conducted by experienced FDA 

laboratory personnel alone. In the latter case, the laboratory personnel 

should discuss the visit with the home division staff prior to the visit. Ideally, 

analysts familiar with each of the analytical areas to be observed should 

participate.

If the private laboratory is located outside the region of the reviewing 

component, an ORA laboratory or division closer to the laboratory may be 

asked to conduct the visit or, if the distance does not pose too great a 

barrier, analysts from the reviewing laboratory may conduct the on-site 

assessment. In the latter situation, the home district of the private 

laboratory should be notified and consulted prior to the visit.

In all cases, inspectors and analysts who conduct on-site assessment visits 

should be fully briefed with any information about the laboratory prior to the 

visit. Afterwards, they should prepare a memorandum describing the visit. 

The memo should be sent to the home division of the private laboratory.

The private laboratory or the importer or broker may request a copy under 

the Freedom of Information Act.

D.

E.

F.

7. Consultations

Private laboratories often request FDA guidance and advice. The most frequently asked 

questions are about the methods to be used. FDA should be helpful in providing this 

information, although it is ultimately the responsibility of the importer and the private 

laboratory to provide FDA with the documentation and assurance needed. As long as 

information from standard sources is provided, such as a referral to the AOAC Official 

Methods of Analysis, it need not be documented by the FDA employee. If the advice is to 

an alternate source, or involves other issues, then it should be documented in a memo of 

the conversation. A copy of the memo should be given to the compliance officer and a 

copy kept with the file on the private laboratory.

Meetings

Meetings may be held between the private laboratory and the ORA laboratory and/or the 

home division. Sometimes, these are held at the request of the private laboratory. More 

commonly, they are held when FDA feels that they are needed to facilitate the resolution

8.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 12 of 20
of unresolved problems involving the private laboratory. If there is a particular entry 

involved, the importer or broker should be notified and invited to such discussions. The 

ORA laboratory and division staff should provide the firms with clear explanations as to 

why the analytical results are not acceptable and with the criteria that is to be met for 

acceptance. The increase in understanding that frequently results, and the ensuing 

discussion can often be helpful in resolving outstanding problems. At each of these 

meetings, a secretary (from FDA) should be designated. The secretary is responsible for 

preparing notes of the meeting, which should be provided to the home division and 

copied to the file.

Continuing Problems

If indications are that the private laboratory has not made the requested corrections, the 

agency may continue to find the analytical packages unsatisfactory on an entry-by-entry 

basis. ORS should be notified of such on-going situations.

Time Reporting

Operating employees should report the time spent reviewing private laboratory packages 

in the Compliance Management System (CMS). All other private laboratory related 

activities should be recorded in FACTS (Field Accomplishments and Compliance 

Tracking System).

Requests for Referrals

Persons in need of the services of a private laboratory often call the agency asking for 

referrals. FDA does not make such recommendations, but callers may be referred to 

organizations of private laboratories such as the American Council of Independent Labs 

(ACIL) at 1629 K. St., NW, Suite 4000, Washington, D.C. 20006-1633 (202-887-5872 or

www.acil.org); or ASTM at 1916 Race St., Philadelphia, PA 19103-1187 (www.astm.org). 

If a LAAF accredited laboratory is needed, they may refer to the LAAF dashboard FDA

Dashboards - Laboratory Accreditation for Analyses of Foods Program. 

LAAF Program

The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation 

for Analyses of Foods (LAAF) establishes a laboratory accreditation program for the 

testing of food in certain circumstances. Under the LAAF program, FDA will recognize 

accreditation bodies (ABs) that will accredit laboratories to the standards established in 

the final rule (referred to as LAAF-accredited laboratories). For more information about 

the LAAF program see FSMA Final Rule on Laboratory Accreditation for Analyses of

Foods (LAAF) | FDA .

9.

10.

11.

12.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 13 of 20
Document History

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

Change History

For the most current and official copy, check QMiS.

Revision 

# Change

1.2

Table of Contents – added Document History

Section 7.4 – removed paragraph on Referree Samples.

Attachment 2 – boxes replaced with _

1.3 Section 7.3.1 – first sentence in third paragraph revised.

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

7.3.2 Packages from foreign laboratories – Divisions changed to appropriate Offices

02 The document was reformatted.

03

• Changed title

• Added information pertaining to upcoming implementation of FSMA final rule on 

Laboratory Accreditation for Analysis of Foods (LAAF).

• Replaced mention of “Districts” to “Division” due to recent organization sunsetting of 

Districts.

• Clarified reviewers as “Qualified FDA Personnel” vs. “Laboratory analysts”

• Added inclusion of method verifications to documentation that should be submitted.

• Added “private laboratory” in addition to importer for compliance officer communications 

sent.

• Changed notification of on-going problems from DFS to ORS.

• Added inclusion of FACTS for time reporting.

• Document transferred and reformatted to ORA Template-000054 ORS Document 

Template.

Revision 

#

Status* 

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

1.2 R 06/22/05 LMEB LMEB

1.3 R 11/10/05 LMEB LMEB

1.4 R 01/30/13 LMEB LMEB

02 R 08/13/2019 LMEB LMEB

03 R SEE QMIS LMEB LMEB

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 14 of 20
Attachments

List of Attachments

Attachment A - Example of Collection Report .............................................................16

Attachment B - Example of Analyst Background and Training Record........................17

Attachment C - Example of Analytical Report..............................................................18

Attachment D - Private Laboratory Package Review Guide ........................................19

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 15 of 20
Attachment A - Example of Collection Report

Brokers’ reference no.

Port of entry Truck license no. 

(Name, address, phone) 

Grower Shipper 

Description of product

Description of container 

Brand name 

Labeled size Product code

Invoiced quantity Actual quantity

Copy of invoice attached? Y/N Package label attached? Y/N

Carton label attached? Y/N Bulk label attached? Y/N

Warehouse/freezer lot no.

Address where sampled

Method of collection

No. of cartons/drums opened

No. of packages/portions from each

Weight/volume of portions collected

Identified by collector on each portion as

Method of sealing

Observations or comments about the lot, container(s) or anything else relative to the integrity of the sample 

collected (required): 

Description of the chain of custody of the sample

Date of collection Signature

Collector’s name 

Date Agency 

Signature 

FDA agent notified of intent of sample collection

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 16 of 20
Attachment B - Example of Analyst Background and Training Record

Laboratory Name

Analyst's Name Title

Years employed in present position Total years as an analyst 

Highest education received (institution, degree [if any], dates, major subject)

Certifications, Technical licenses (Granting body, date, brief description of entitlement)

Type of Analysis Employee is Qualified to Perform (Check all that apply, but document each separately)

_Macroscopic/Microscopic Filth _Sensory Decomposition _Chemical Decomposition _Metals _Colors

_Additives _Pesticides _Aflatoxin _Drug Analysis _Condom Testing _Microbiological - Pathogenic and nonpathogenic organisms _Other

Provide information about training, with dates, that qualifies the employee to perform the analysis referred to

above. (Use back of form if more space is needed.)

Provide information about work experience, with dates, that qualifies the employee to perform the analysis 

referred to above. (Use back of form if more space is needed.)

Laboratory Director Date 

Signature 

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 17 of 20
Attachment C - Example of Analytical Report

Description of product received

Brokers’ reference no. 

FDA sample no. Laboratory sample no.

Date received Seal intact? Y / N

Condition of sample: frozen refrigerated ambient

Sample description (size, no. of portions)

Container code if present 

Portions identified by collector as

Portions agree with description? Y/N

Date analysis begins Date analysis completed

Method used (reference(s) and any modifications) 

Number of sub samples Amount analyzed per sub 

Total amount analyzed 

How composited

Note: Clearly indicate on each analytical worksheet who did what part of the analysis, with signature(s) and 

dates(s). Equipment used: Identify equipment and parameters used to weigh and process samples, analyze 

extracts, etc.

LABORATORY DIRECTOR’S STATEMENT: Review of records indicate that the product and lot referred to 

in this report have have not been subject to prior analysis by this laboratory. If the lot has been 

subject to prior analysis by this laboratory, copies of the final results are hereto attached. The prior analysis 

was conducted on the following date(s) and covered by the following laboratory report numbers(s):

Signed Date 

IMPORTER’S STATEMENT: The analytical results submitted with this report include all analytical work 

related to this sample performed by this laboratory and all other laboratories which may have conducted the 

analyses.

Signed Date

Notice: The knowing and willful making of any false, fictitious or fraudulent statements or representations in 

any manner within the jurisdiction of any department or agency of the United States is a matter subject to the 

provisions of Title 18 of the U.S. Code, Section 1001

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 18 of 20
Attachment D - Private Laboratory Package Review Guide

1. SAMPLING

a.

b.

c.

d.

e.

f.

Lot is described.

Sample is collected randomly.

Sample is collected from sufficient number of cartons (proper distribution). 

Proper size sample is collected.

Sufficient number of subs are collected. 

Collection is documented/collector is identified.

2. SAMPLE DATA

a.

b.

Sample number on worksheet relates to final report.

Sample is accurately described and relates to invoice (e.g. dimensions for ceramic ware, size of fish, 

shrimp, etc.).

Contents of each sub composited (or portion taken, if whole sub). 

The correct portion of composite is taken and weight is shown.

Where individual subs are analyzed, the correct number of subs examined. 

Sample is correctly prepared.

Sample is correctly stored e.g. temperature. 

Label is submitted if present on the product.

c.

d.

e.

f.

g.

h.

3. ANALYTICAL METHOD

a. The correct method is used and cited. Non-official methods are validated. Current versions of official 

methods are used.

Each step of the method is followed.

Deviations from official method are explained and validated. 

Use of special reagents and equipment is described.

All equipment is identified to be traceable to its QA records. 

No unresolved analytical problems are evident.

All analytical attempts are included, and discarded results are explained. 

Recovery and blank data are acceptable.

Calculations are clear, accurate, and easy to follow.

All raw data, including chromatograms and spectra and reproductions of TLC plates, are submitted, 

as well as printouts of reader instruments, e.g. Vidas.

Laboratory conclusions are supported by analytical results.

All analysts sign worksheet and ‘who did what’ is clearly indicated. ‘When’ can also be determined 

as called for by the method (e.g. for microbiological analysis).

b.

c.

d.

e.

f.

g.

h.

i.

j.

k.

l.

4. STANDARD DATA

a.

b.

c.

d.

Source of standard is cited.

Preparation dates and preparer of primary and working standards are cited. 

Weights, dilutions, and concentrations of standard materials are documented.

Standard curve has the correct number of points; sample results are within the limits of the standard 

curve.

Standard curve submitted unless regression analyses used to calculate sample results. 

Standard and/or blank injections bracket sample injection, as needed.

e.

f.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 19 of 20
5. INSTRUMENT PARAMETERS

The following parameters are documented:

a.

b.

c.

d.

e.

f.

g.

h.

i.

j.

k.

l.

Name & model of instrument, accessories used 

Parameters for operation of instrument 

Wavelength used

Lamp power settings 

Type of flame used

Column type, ID., and length used 

Gas/Liquid phases med

Flow rates

Detector and mode used 

Temperature settings 

Attenuation

Chart speed

6. CONDOMS/GLOVES

a. Sample is of a single type and brand.

b. Proper sample size is collected and examined according to method and is of scheduled number to 

be examined (lots, glove size, use).

c. Label is reviewed.

7. MICROBIOLOGICAL ANALYSIS

a.

b.

Batches of media are identified with QA numbers.

Positive and negative controls traceable to reference cultures are run concurrently with sample 

analysis and carried through until the sample is completed. Controls are within range for a valid 

assay.

Refrigerators, freezers, and water baths are identified on the worksheet. 

Biochemical reactions/patterns are obtained in the analysis.

Expired media, reagents or test kits are not used in the analysis.

FDA guidelines followed on such items as number of colonies to pick.

Each step of the method is followed, with media, incubation temperatures, amounts transferred, etc. 

being documented.

c.

d.

e.

f.

g.

To be confirmed during on-site assessment visits:

a.

b.

c.

d.

e.

f.

Media used in microbiological analysis undergoes QA checks for pH, sterility, and growth promotion. 

Batches of media have expiration dates.

Batches of media are traceable to autoclaves and autoclave runs. 

Autoclave processing cycles are validated with biological indicators. 

Refrigerator, freezer, and water bath temperatures are monitored daily.

Laboratory grade water, free from traces of dissolved metal, bactericidal, and inhibitory compounds 

is used to prepare media, reagents, and dilution blanks.

8. PERSONNEL

Analyst CVs are on file or are submitted with worksheet packages. CVs should include 

analyst’s training or experience or both in the areas covered by the analysis.

For the most current and official copy, check QMiS.

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS

Office Regulatory Science (ORS)

Document Number: 

MAN-000051

Revision #: 03

Revised:

08 Dec 2023

Title:

ORA Lab Manual Vol. III Section 7 - Private Laboratory Analytical Packages Page 20 of 20