Drugs

CGMP Violations at Tris Pharma

A 2/14-3/20/17 inspection at Tris Pharma, Monmouth Junction, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/26 Warning Letter. Specific violations noted in the letter were

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter reminds Tris of its obligations as a Pfizer contractor to manufacture drugs that conform with CGMP. “FDA regards contractors as extensions of the manufacturer,” it says. FDA strongly recommends that Tris engage a qualified consultant to assist it in meeting CGMP requirements.

Tris was told to promptly correct the violations and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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