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CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) September 2016

Issued by:
Guidance Issuing Office
Office of Regulatory Affairs

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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