FDA Warning Letter To Teva Highlights Need For Accurate Root Cause Investigations
Teva left it for US FDA to link dissolution failures to errant laser drilling of extended-release tablets. Warning letter underscores importance of timely, accurate root cause investigations.
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Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
Akorn has been hit with its second warning letter this year, this time for similar issues at a different site, where the US FDA found the firm failed to adequately address problems with impurities and bottle defects. The Akorn letter may also be symptomatic of a larger problem being seen by the agency in the growing number of faulty root cause investigations.
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.