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.
During an inspection in October, investigators found that the computer operating the CDMO's spectrophotometer, a tool used to determine a drug's strength, was open for employees to access and even delete files without the company's quality control unit ever knowing the difference.
In a response to an FDA Form 483 highlighting the issues, Stason admitted the computer's software was not working as intended and that the company did not have the ability to troubleshoot the problem on its own.
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Those data failings are a big problem, particularly after the FDA cited dissolution issues in one lot of Stason's chemotherapy drug temozolomide that eventually led to a recall.
During its inspection, the FDA noted that multiple lots of temozolomide tested out-of-spec for dissolution rates—an indicator of drug strength. Stason initially suspected "overdrying" as the cause of the variability in the test results, but the FDA found the CDMO never determined the root cause of the issue and didn't try that hard to do so.
"Your firm was unable to demonstrate that dissolution failures were indeed occurring due to overdrying of the capsules," the FDA said.
The FDA called for a full review of the CDMO's temozolomide manufacturing, including a full accounting of the drug's dissolution testing. Stason said in a letter to the FDA that it was also seeking to address the quality control issues with its spectrophotometer.