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

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

Source: 
Fierce Pharma
snippet: 

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.