Description
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.
Scope & Applicability
Stakeholders
2Entities that often prepare Private Laboratory Analytical Packages.
Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Regulatory Context
Attributes
1A factor assessed during the non-technical review of a PLAP.
Related CFR Sections (1)
- 21CFR1.94§ 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic noticRead full regulation →
See Also (3)
- Small Entity Compliance Guide: What You Need To Know About Administrative Detention of Foods (Status: Final)
- Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE (Status: Draft)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)