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

 
• By Bowman Cox

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.

A part of the solution
the problem and the solution • Source: Shutterstock

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 methods that were inadequately validated for drug GMP quality testing

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