FDA 483 - Fenwal International, Inc. - September 24, 2021

Fenwal International, Inc. in Maricao, PR, was cited for significant deficiencies in its manufacturing operations for sterile drug products. The inspection revealed inadequate investigations into unexplained discrepancies and out-of-specification events, as well as deficient complaint records, including a failure to thoroughly investigate a fatal transfusion reaction linked to bacterial contamination. Furthermore, the firm lacked established control procedures to validate manufacturing processes and failed to implement adequate procedures to prevent microbiological contamination, leading to repeated recoveries of harmful bacteria.