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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 1 of 12

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................2

2. Scope .......................................................................................................................................2

3. Responsibility............................................................................................................................2

4. Background...............................................................................................................................3

5. References ...............................................................................................................................3

6. Procedure .................................................................................................................................3

6.1. Introduction ....................................................................................................................3

6.2. Results ...........................................................................................................................4

6.2.1. Analytical Worksheet .......................................................................................4

6.2.2. Collection Report .............................................................................................5

6.2.3. General Continuation Sheets...........................................................................5

6.2.4. Attachments .....................................................................................................5

6.3. Field Accomplishments and Compliance Tracking System (FACTS) or a Laboratory 

Information System (LIMS) ............................................................................................5

6.4. Other ..............................................................................................................................6

6.5. Deviations and modifications .........................................................................................6

6.6. Additional analysis .........................................................................................................6

6.7. Opinions and Interpretations..........................................................................................7

6.8. Reviewing Analytical Results .........................................................................................7

6.9. Authorizing Analytical Results Prior to Release.............................................................7

6.10. Reporting........................................................................................................................7

6.10.1. Reports issued to internal (within FDA) offices ................................................7

6.10.2. Abbreviated reporting.......................................................................................7

6.10.3. Reports issued to agents responsible for any products tested by an ORS 

laboratory 8

6.10.4. Reports issued in cooperation with industry and other Federal and State 

agencies 8

6.11. Format of Reports ..........................................................................................................9

6.12. Issuing Modifications or Amendments to Reported Findings .......................................10

7. Glossary/Definitions................................................................................................................10

8. Records ..................................................................................................................................11

9. Supporting Documents ...........................................................................................................11
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 2 of 12

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10. Document History ...................................................................................................................12

11. Change History.......................................................................................................................12

12. Attachments............................................................................................................................12

1. Purpose 

This procedure defines the process for reporting analytical findings and 

conclusions as prescribed by the agency.

2. Scope

This procedure applies to all Office of Regulatory Science (ORS) laboratories 

and the release of information.

3. Responsibility 

A. Laboratory Director:

1. is responsible for ensuring the timeliness, accuracy and 

completeness of all analytical information reported by the laboratory; 

and

2. reviews, or designates reviews of violative worksheets prior to 

release by the laboratory.

B. Laboratory Management:

1. are responsible for ensuring the timeliness, accuracy and 

completeness of all analytical information reported by the analyst; 

2. are responsible for ensuring that laboratory analysts comply with the 

data and information recording procedures; and

3. review analytical findings and supporting records generated by 

analysts, enter related conclusions, and sample classification codes 

into web application, such as Field Accomplishments and 

Compliance Tracking System (FACTS) or Laboratory Information 

Management System (LIMS).

C. Analysts:

1. are responsible for capturing and recording accurate and complete 

analytical information on worksheets, continuation sheets, electronic 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 3 of 12

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lab notebooks, or other records in accordance with the instructions 

of this procedure; and

2. are to complete worksheets and enter analytical observations and 

findings into the web application, such as FACTS or LIMS, in a 

timely manner.

4. Background 

None

5. References 

A. Food, Drug and Cosmetic Act, Section 704(d), Factory Inspection 

B. Field management directive No. 147, procedure for release of analytical 

results pursuant to section 704(d).

C. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories. Section 7.8.

D. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.

6. Procedure 

6.1. Introduction

The worksheets printed or electronic, and applicable supporting records (e.g., 

labels, packaging, promotional materials, instrument charts, exhibits, 

memorandums, controls) referred to in this section are used to provide the 

written or electronic account of analytical findings that either support regulatory 

action or serve to classify the sample as non-actionable. This documentation is 

prepared so the history of the sample can be reconstructed with confidence, 

including details on which the analyst may respond to queries or challenges 

months or years later. They give an objective account of the sample handling 

and analysis efforts from the time of receipt to the time analysis and 

investigative efforts are concluded. There is no doubt about what was done, 

how it was done, who did it, and with what accuracy and precision the work 

was accomplished. 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

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Revision #: 02

Revision Date:

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Title: 

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The worksheet package or electronic file presents a complete picture that can 

be understood by reviewers, even those not technically or scientifically trained, 

and not a part of the analyzing science unit. 

6.2. Results

Analytical findings are presented on the basic worksheets, FDA form FD431(Analyst Worksheet) and FD-431a (General Continuation Sheet) or 

electronic templates, in a clear and concise manner to expedite interpretation 

of the results, especially by non-technical and non-scientific personnel. These 

forms and attachments or electronic lab notebooks make an analytical 

package or electronic file. Whenever possible, the analytical data should be 

tabulated. 

Also, if subsamples with differing codes were individually examined, the results 

are clearly recorded for each code because regulatory action may be based on 

the results of a particular code exclusive of other codes. The following are 

some components of the analytical package.

6.2.1. Analytical Worksheet

The following information is included on the analytical worksheet:

A. Title (i.e. ANALYST WORKSHEET), Block 10 Summary of Analysis;

B. Name of laboratory (e.g. DENL);

C. Unique identification of the worksheet on each page (i.e. sample 

number and page numbering);

D. Identification of the method used;

E. Description of sample to include deviations, additions or exclusions from 

collector’s report;

F. Date received;

G. Date(s) analysis performed;

H. Date reported;

I. Results;

NOTE: Results include the unit of measurement and reflect the correct 

number of significant figures indicated by the analytical method. If 

computer generated results are included in the final report, a statement 

on the report indicating the correct number of significant figures suffices 

when the number of figures presented by the computer exceeds the 

capability of the method. Statistical or other data reflecting accuracy and 

precision are included. 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 5 of 12

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Analytical results are compared with the label, labeling declarations, 

published tolerances and standards, regulatory action levels, 

manufacturer's specifications or other applicable criteria. 

When requested, a statement of compliance or non-compliance with 

requirements or specifications is recorded. 

When discrepancies are found between analytical results and labeling 

statements or other criteria, these facts are set out clearly.

J. Analyst and reviewer signatures.

6.2.2. Collection Report

The report includes, but is not limited to the following information:

A. Name of sampling district;

B. Date of sampling;

C. Identification of the substance, material or product sampled;

D. Reason for collection;

E. Method of collection, how prepared; and

F. Analysis requested.

6.2.3. General Continuation Sheets 

These sheets contain the raw data, calculations, standard preparation, dilution 

schemes, quality control data, equipment used, reagents, media, test 

conditions, deviations, additions or exclusions from the test method, and other 

sample related information.

6.2.4. Attachments 

Attachments can consist of:

A. Instrument generated reports and charts

B. Photographs, 

C. Labels

D. Memoranda

6.3. Field Accomplishments and Compliance Tracking System (FACTS) or a 

Laboratory Information System (LIMS)

Analytical findings and observations are entered into FACTS or LIMS by 

laboratory analysts. Supervisors enter conclusions and laboratory 

classification. The individuals performing the laboratory activities are recorded 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 6 of 12

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in FACTS. The data is obtained by internal clients (FDA) through FACTS or 

electronic file transmission. Laboratory personnel are to make every effort 

possible to ensure the sample information, analytical findings and conclusions 

entered are correct and that any errors are corrected as quickly as possible. 

6.4. Other

The following information is found at the laboratory, but not necessarily 

provided in the analytical packet or web application:

A. Address of the analyzing laboratory;

B. Address and contact information of the sampling district;

C. Statement to the effect that the results relate only to the item tested; 

and

D. Estimated uncertainty of measurement

6.5. Deviations and modifications

Whenever there is a need to (a) deviate from or add to an official method, (b) 

use an entirely new method for a sample analysis or (c) modify test conditions 

such that it may affect the integrity of the analysis and interpretation of results, 

these deviations or new methods are comprehensively described by the 

analyst. Depending upon the magnitude of the deviation or change, this can be 

a relatively short entry on a continuation sheet (FD-431a), web application 

comment section, or as a separate memo. This memorandum describes the 

deviations and new methods employed and how the proper performance of the 

new or modified method was demonstrated in terms of accuracy, precision, 

specificity for the product being analyzed, and the estimated uncertainty of the 

measurements when this is needed for the validity or application of the 

examination. The validation techniques used will vary depending upon the 

situation.

6.6. Additional analysis

Whenever a check or additional analysis is performed, a new FD-431 or 

electronic lab notebook is started. However, blocks 8 and 9 need not be 

repeated on these second worksheets. In addition, the description of the 

container, labeling, code in block 10 on the second worksheet need not be 

repeated unless requested or instructed to do so. For those items remaining 

the same on the second worksheet, enter the statement See original analysis, 

and under the analysis category enter the subsample numbers retested 

whenever applicable. The information entered in block 7 is complete in 

description to demonstrate continuity of sample handling.
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 7 of 12

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6.7. Opinions and Interpretations

The laboratory management interprets the analytical findings and assigns a 

sample classification in FACTS or LIMS. The laboratory classifications are 

defined in the ORA Laboratory Manual Volume III Section 3. Other opinions 

and interpretations by laboratory management may be included in the 

analytical package. These may be comprised of, but not limited to the following 

records:

A. Opinion on the conformity of the results with regulatory requirements;

B. Recommendations on how to use the results; and

C. Guidance to be used for improvements, when needed and applicable.

6.8. Reviewing Analytical Results

A. Worksheet Check –A second qualified analyst or supervisor will review 

the package prior to it being forwarded to final reviewing official.

B. Supervisor Review – Following the worksheet check, a supervisor 

reviews it for accuracy and completeness.

6.9. Authorizing Analytical Results Prior to Release

Analytical packages for non-actionable samples will be approved by the 

responsible Supervisor or designee. Analytical packages for actionable 

samples are approved by the laboratory director or designee. The responsible 

Supervisor or Laboratory Director enters their conclusion(s) and sample 

classification code(s) into FACTS. 

6.10. Reporting

6.10.1. Reports issued to internal (within FDA) offices 

Reporting laboratory findings to compliance and other internal FDA offices is 

accomplished using the FACTS application, LIMS, or, if applicable, via 

distribution of an analytical package to the division responsible for the sample. 

Each laboratory maintains a record of package distributions. 

6.10.2. Abbreviated reporting 

Analytical findings and conclusions may also be reported using abbreviated 

procedures designed to minimize laboratory resources when such is 

authorized by the laboratory director, the Office of Regulatory Science (ORS) 

Headquarter Units, and the applicable compliance program. The exact manner 

in which abbreviated reporting is accomplished is determined on a case by 

case basis to meet client needs. 
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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 8 of 12

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6.10.3. Reports issued to agents responsible for any products tested by an 

ORS laboratory 

A. Section 704(d) of the Food, Drug and Cosmetic Act requires that the 

results of an analysis of a sample obtained during an inspection of an 

establishment where food is manufactured, processed or packaged be 

reported promptly to the owner, operator, packer or agent in charge. 

B. Form FDA 1551 shall be mailed or faxed to the responsible firm within 

two (2) working days of approval of the Sample Summary Report. The 

sample description includes the following:

1. The nature of the sample, number and size of the units examined, 

and the code marks of the subdivisions examined.

2. The results of analysis described in simple (lay) terms whenever 

possible, and restricted to addressing filth, decomposition or other 

factors causing the food to be unfit for food. Details should be given 

regarding any factors in the analysis that are significant in terms of 

the possible violation. A general summary should be provided on 

factors that are not significant. 

3. Form FDA 1551 shall not list the methods employed, conclusions 

drawn from the analysis, any details regarding the manner in which 

the sample was handled prior to the analysis, explanation of the type 

of examination made, or the results of examinations for factors other 

than filth, decomposition, or those causing the food to be unfit for 

food. These forms shall also not be mailed to other than the owner 

or manufacturer, processor or packer from whom the sample was 

collected.

6.10.4. Reports issued in cooperation with industry and other Federal and 

State agencies

A. Unsolicited requests for analytical results on any product may be sent to 

any firm, individual or cooperating agency that, in the judgment of the 

responsible program, has a legitimate interest in the results and when a 

useful purpose will be served.

B. Specific guidance regarding when and how laboratory information is to 

be shared will be provided by the division responsible for the products 

involved on a case-by-case basis.

C. On occasions where a laboratory enters into an interagency agreement 

with an external agency (i.e. State or local agency) to share analytical 

test results on the food, drug, cosmetic or medical device products 

being tested, this data is shared in compliance with the established 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

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Title: 

Reporting Laboratory Results Page 9 of 12

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agreement. As a minimum, this agreement includes terms and 

limitations designed to protect the privacy of the clients whose products 

have been tested.

6.11. Format of Reports

The general format of the analyst worksheet consists of three parts:

A. Heading which includes these items: 

1. Product,

2. Sample number,

3. Seals,

4. Date received,

5. Received from,

6. Lab,

7. Description of sample,

8. Net Contents, and 

9. Labeling.

B. Body or Summary of Analysis which includes these subparts:

1. Container,

2. Labeling,

3. Code,

4. Product,

5. Analysis,

6. Method, and

7. Results.

C. Closing which includes vital information:

1. Reserve sample,

2. Conclusion 

3. Signatures (worksheet check) on hard-copy worksheet,

4. Date reviewed on hard-copy worksheet, and

5. Date reported on hard-copy worksheet.
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ORA Laboratory Manual Volume II

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Revision Date:

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6.12. Issuing Modifications or Amendments to Reported Findings 

Material amendments to analytical results that have already been reported are 

made only in the form of an additional record or data transfer. These reports 

are flagged at top left corner on FDA 431 as Additional Analysis or Amended 

Report with the sample identification (unique package or sample number). 

These amendments are to clearly identify the sample or samples involved and 

describe the changes, additions and corrections being made and the rationale 

for why they are needed. The requesting official must also be contacted with 

notification of the amended report.

Transcription errors that do not affect the data, i.e. incorrect dates, are 

changed on the original analyst worksheet or if applicable, in FACTS or LIMS.

7. Glossary/Definitions 

A. Original analysis – The initial examination conducted on a 

representative portion of the sample is an original analysis. 

B. Check analysis – An analysis performed by a second qualified analyst 

to confirm a finding that may be used by FDA or cooperating agencies 

in a regulatory action is a check analysis. 

C. Additional analysis – Additional analyses performed on a sample to 

obtain information not provided by the original set of analyses or to 

verify originally reported analytical results is an additional analysis. 

Additional analysis may be performed on the original sample composite 

or extract, or an intact and unanalyzed unit of the sample.

D. Amended report – corrected report due to error or change that directly 

affects data

E. Compliance sample – A compliance sample is collected on a selective 

basis as the result of an inspection, complaint or other evidence that 

there may be a problem with the commodity.

F. Surveillance sample – A surveillance sample is collected on an 

objective basis where there is no evidence or suspicion of a problem 

with the commodity.

G. Consumer Complaint Sample – A consumer complaint sample is 

collected from a consumer who is registering an official complaint 

(verbal or written) regarding the quality of a FDA regulated product.

H. Follow-up (sample) to consumer complaint –A follow-up sample is often 

denoted by FU to CC. A follow-up to a consumer complaint is a sample 
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Document Number:

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Title: 

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collected as a result of a complaint but not collected from the 

complainant.

I. Dealer holding sample – A dealer holding sample indicates that the 

dealer is holding the lot sampled. Normally, the dealer would like to be 

notified of the analytical results as soon as possible.

J. Split sample – A split sample indicates one portion of the sample is in 

the possession of one science unit and another portion has been sent to 

another science unit.

K. Sample classifications – Samples are assigned to different regulatory 

decision-making classes (1-5) by laboratory supervisors based upon the 

results of the laboratory’s examination.

L. Factory food samples – Factory food samples consist of raw materials, 

in-process, and finished products collected to demonstrate 

manufacturing conditions and are flagged as such on the FACTS 

collection report. 

8. Records 

A. FACTS data

B. LIMS data

C. Analytical package

D. Abbreviated packages

E. Form FDA 1551

F. Reports to industry

G. Modifications and amendments to reported findings

H. Import Salmonella Template

I. Drug Survey Template

9. Supporting Documents 

A. Regulatory Procedures Manual (RPM)

B. FACTS Reference Guides

C. LIMS Reference Guides
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.10

Revision #: 02

Revision Date:

06/06/2019

Title: 

Reporting Laboratory Results Page 12 of 12

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10. Document History

Revision

#

Status*

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

1.2 R 11/16/05 LMEB LMEB

1.3 R 08/15/08 LMEB LMEB

1.4 R 01/22/13 LMEB LMEB

1.5 R 05/08/14 LMEB LMEB

02 R 06/06/2019 LMEB LMEB

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

11. Change History

Revision 

# Change

02 Revisions made as needed to align this procedure with new ISO/IEC 17025 and 

AOAC requirements. Revision to formatting and policy clarifications were also made.

12. Attachments

None