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.

Recuperar contrasena