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# CGMP Violations at Quali-Controle
- URL: https://www.fdaweb.com/cgmp-violations-at-quali-controle/
- Published: 2018-03-13T12:00:00.000Z
- Updated: 2026-09-14T23:53:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140963

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](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599876.htm?ref=fdaweb.com). 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.