French Drug Contract Tester Warned for GMP Violations
The FDA warned a French drug contract testing laboratory following a September inspection that revealed deficiencies in testing practices and discrepancy investigations.
The agency said Quali-Controle & Quali-Controle C.E.BAC used non validated test methods to assess its customers’ drug products. The firm’s inadequate response was to add a comment to its certificate of analysis to say it used non-validated test methods.
In addition, the firm’s atomic absorption analysis of a sample and its retest were both out-of-specification, and were invalidated without justification or inquiry. The company said dirty glassware in prior tests and preparations caused the failures, and that it resolved the problem by cleaning them.