Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem

The GMP non-compliance concerns the US Food and Drug Administration recently raised about Valisure LLC’s drug product testing activities are off base, Valisure LLC asserts, because rather than testing drug products for manufacturers, it screens them for buyers, serving as an independent check on the pharmaceutical manufacturing sector’s quality.

A recent untitled letter from the FDA said Valisure failed to comply with certain distribution-related Drug Supply Chain Security Act (DSCSA) good manufacturing practice requirements and that it used analytical...