Question 1

What is an FDA detention and how is it resolved?

Accepted Answer

An FDA detention is issued via a Notice of FDA Action when an import appears to violate the FD&C Act. Resolution typically requires a timely, defensible response, often a Private Laboratory Analytical Package (PLAP) demonstrating the absence of the targeted violation, submitted within the NOA response window.

Question 2

How can a supplier be removed from an FDA Import Alert?

Accepted Answer

Removal generally requires evidence of corrective action and consistent compliant entries, often supported by a Foreign Supplier Verification Program (FSVP) and analytical results demonstrating the product meets US requirements.

Question 3

What is a PLAP?

Accepted Answer

A Private Laboratory Analytical Package is the complete analytical submission comprising sampling, chain of custody, and accredited laboratory results, used to overcome an FDA detention.

Centro de Inteligencia Regulatoria

Referencias Fundamentales

CFR Title 21

FSMA Overview

Import Alert Reference

FSVP Regulations (21 CFR Part 1 Subpart L)

Programas de Cumplimiento

FSVP Importer Guide

FDA Regulatory Overview

Food Import Procedures