CGMP Violations at Quali-Controle

A 9/14-9/15/17 FDA inspection at Quali-Controle & Quali-Controle C.E.BAC, Meru, France, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 3/5 Warning Letter. Specific violations cited were: 

•        failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; and
•        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.

The letter notes that as a contract laboratory, the firm has a quality agreement with its customer specifying the testing method that must be used for a drug product, and failed to follow the agreement.

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