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28 Aug 2016

Frontida BioPharm received US FDA warning letter

USFDA sends the warning letter to Frontida BioPharm’s two manufacturing units, due to discrepancies in records related to manufacturing practices.
FDA stated the quality unit (at the site) failed to ensure that cGMP-related (current good manufacturing practices) records are accurate, contain appropriate documentation and are consistent with its standard operating procedures.
In additional revelations of serious lapses, the FDA noted that the quality unit at the Pennsylvania drive unit knowingly released 27 lots of various strengths of clonidine tablets on or about March 5, 2015, despite evidence
FDA also stated the quality unit (at the site) failed to ensure that cGMP-related (current good manufacturing practices) records are accurate, contain appropriate documentation and are consistent with its standard operating procedures.

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