Compliance Policy Guide  
Sec. 150.200 Compliance Review of Private Laboratory 
Analytical Packages (PLAPs) 
 
Guidance for FDA Staff  
 
Submit one set of either electronic or written comments on this guidance at any time. 
Submit electronic comments to http://www.regulations.gov. Submit written comments to 
the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number of this Compliance Policy Guide: FDA-2016-D-3338.  
 
For questions regarding this document contact the Director of the Division of Import 
Operations with the Office of Regulatory Affairs (DIO/ORA) at 301-796-0356.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
 
September 2016  Contains Nonbinding Recommendations 
Table of Contents  
 
I.  Introduction 
 
II.  Background 
 
III.  Policy 
 
A. Non-Technical Review of PLAPs by Compliance 
Personnel 
B. District Assessment of PLAPs after Technical 
Review 
 
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Compliance Policy Guide  
Sec. 150.200 Compliance Review of Private Laboratory 
Analytical Packages (PLAPs) 
 
Guidance for FDA Staff  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to 
discuss an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the telephone number 
listed on the title page of this guidance.  
 
I.  Introduction:  
 
The purpose of this document is to provide guidance for FDA staff when receiving and 
reviewing private laboratory analytical packages (PLAPs).  Importers typically submit 
PLAPs to FDA to provide information regarding the admissibility of articles that are held 
under detention without physical examination (DWPE) due to the appearance of a 
violation.  The policy described in this document applies to: 1) FDA compliance 
personnel review of the non-technical aspects of a PLAP; and 2) FDA compliance 
personnel determination of admissibility after the technical review of a PLAP is 
completed by an ORA Field Laboratory. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
II. Background:  
 
Section 801 of the Federal Food Drug & Cosmetic Act (FD&C Act) authorizes FDA to 
refuse admission of imported articles if it appears from the examination of such samples 
or otherwise that the article is in violation of applicable provisions of the FD&C Act.  To 
carry out the provisions of section 801(a), FDA may detain articles that appear violative 
and inform the importer of the nature of the violation and the right to introduce testimony 
regarding the admissibility of the article (see 21 CFR 1.94).  Depending on the 
information submitted by the importer, the article may either be permitted or refused 
entry into the United States. 
 
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FDA utilizes detention without physical examination (DWPE) when information 
indicates that future shipments of a product or products offered for entry appear violative 
within the meaning of section 801(a). 
 
Section 801 provides the importer with the right to introduce testimony bearing on the 
admissibility of the articles.  When an importer submits evidence to FDA to demonstrate 
admissibility, it is often in the form of private laboratory reports, known as Private 
Laboratory Analytical Packages (PLAPs), often prepared by third-party laboratories.  
 
The Agency evaluates the PLAPs to determine whether and how the PLAPs bear on the 
admissibility of an article.  This evaluation consists of two parts:  (1) a non-technical 
review, to ensure the PLAP is complete, to verify sample integrity and relevance to the 
detained shipment, to assess if sound sample collection methods have been used, and to 
verify that the reported results indicate that there is no apparent violation; and (2) a 
technical review, to ensure that the analytical result is scientifically valid.  The policy 
stated below applies to FDA compliance personnel review of the non-technical aspects of 
a PLAP.  The determination of admissibility is typically made after the technical review 
of a PLAP is completed by an ORA Field Laboratory or other designated scientific 
authority within the agency.  PLAPs reporting clearly violative results do not require a 
technical review.  If the results are not clearly violative, the PLAPs can be sent for 
technical review. 
 
III. Policy:  
 
A. Non-Technical Review of PLAPs by Compliance 
Personnel 
 
When FDA receives a PLAP, FDA compliance personnel conduct a review of the non-
technical aspects of the package.  FDA compliance personnel utilize a checklist to 
determine if the package is complete and if the package follows the sampling 
recommendations described in ORA Laboratory Manual, Section 7  Private Laboratory 
Guidance.  The checklist consists of the questions listed below. 
 
If the answer to any of the questions is No, compliance personnel may determine that it 
is appropriate to relay this information to the importer.  If that occurs, compliance 
personnel will provide the importer an opportunity to address the identified issue(s), 
which can include providing a rationale for why the items in the checklist are not 
applicable or why an alternative approach is warranted. If the issue(s) cannot be resolved, 
the PLAP may be considered unacceptable.  
 
i.  Initial Questions: 
a.  Does the lab analysis address the reason for the detention? 
b.  Does the lab analysis demonstrate that the articles are non-violative?  
PLAPs reporting clearly violative results do not require a technical review.  
 
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ii.  Questions to determine if the PLAP is complete: 
a.  Are the entry number and, if applicable, line number correct in the report? 
b.  Is the private lab sample number consistent throughout the report? 
c.  Are the dated signatures included in the final report for the importer and 
the private lab? 
d.  If there was a prior analysis, was the prior analysis field filled out within 
the private labs statement? 
e.  If there was a prior analysis, was the previous report submitted with the 
current report? 
f.  Where included, are photos and labels legible? 
g.  Are the raw analytical data and worksheets provided in the report? 
 
iii.  Questions to determine if the sample was collected appropriately and relevant 
to the detained product: 
a.  Are the sample collector and his/her organization identified on the 
collection report? 
b.  Is the product collected and analyzed the same as the product detained?  
c.  Is the product description consistent throughout the report? 
d.  Is the actual quantity available for sampling reported on the collection 
report consistent with the entry documents and declaration for the 
indicated product(s)? 
e.  Is the collection date indicated in the collection report? 
f.  Is the sequence of dates for sampling and analysis consistent, e.g., was the 
analysis conducted after the sample was collected?  
g.  Is the sample collection appropriate? Factors to consider include, but are 
not limited to: (1) Is the sample representative of the detained product?; 
(2) Were a sufficient number of sub-samples collected based on the size of 
the lot? Consult ORA Laboratory Manual, Section 7  Private Laboratory 
Guidance, for additional factors to consider. If additional information is 
required to make this determination, contact the private lab. 
 
If the package is found to be acceptable for the non-technical portion, the package is 
generally forwarded to an ORA Laboratory or other specified entity for review of the 
technical portion of the PLAP. If the district is unable to determine if the PLAP non-
technical review is acceptable or unacceptable, the district should refer the issue to DIO 
who will consult with the appropriate Center as needed. 
 
B. District Assessment of PLAPs after Technical Review 
 
ORA Field Laboratories typically conduct the technical reviews of the PLAPs.  The 
results of the review of the technical portion of the package are reported to the 
appropriate district compliance personnel. 
 
If the technical review conducted by the FDA reviewing entity classifies the PLAP as 
unacceptable, then FDA will inform the importer of the unacceptable nature of the 
PLAP, and will provide the importer an opportunity to respond.  Depending upon the 
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nature of the deficiencies noted, FDA may provide the importer an opportunity to correct 
the deficiencies and submit the PLAP for re-evaluation.  Some deficiencies may not be 
correctable. 
 
FDA will review requests to reanalyze products on a case-by-case basis.  There is no 
automatic right to reanalyze products after they have been analyzed and the results 
submitted to FDA as part of testimony regarding the admissibility of an article. 
 
Issued: 09/14/2016 
 
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