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Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
FDA issued a warning letter to Laboratoire Sintyl S.A. after a June 2016 inspection of the company’s Geneva facility. The company was cited for current good manufacturing practice (CGMP) violations including failing to test the strength of active ingredients.
During the inspection, FDA found the company had failed to establish quality control unit responsibilities and procedures for reviewing out-of-specification results and customer complaints. Investigators were told that the company had no independent quality unit.
Specific quality issues that were observed included a failure to test finished batches of drug product for identity and strength of active ingredients and a failure to identify components sourced from suppliers. A lack of proper cleaning and maintenance was also observed.
FDA recommended the company engage a qualified consultant to help meet CGMP requirements. The agency stated it may refuse admission of drug products that have not been manufactured under CGMP guidelines.