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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.