FDA 483 - Fenwal International, Inc. - September 24, 2022

Fenwal International, Inc. in Maricao, PR, was cited for significant deficiencies in its drug manufacturing operations, particularly concerning quality control, environmental monitoring, and aseptic processing. The inspection revealed failures in investigating out-of-specification results, maintaining clean and properly designed facilities and equipment, and establishing adequate procedures to prevent microbiological contamination. These issues indicate a high risk of product contamination and compromise of drug product quality.