
FDA Warns Swiss Company
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
FDA issued a
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.
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