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FDA rails at California CDMO for failing to secure data used to determine strength of its drugs

July 22, 2020


Generally speaking, the quality of a manufacturer’s data is only as good as the policies in place to ensure the information. Allowing all employees to access those data files—and even possibly delete them—isn’t exactly a good policy, and the FDA is letting a California CDMO have it for that exact failing.

The FDA raked Irvine, California-based Stason Pharmaceuticals for allowing regular employees to access key data used to determine the quality of final drug products, the agency said in a warning letter published online Tuesday.

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