FDA 483 - Viwit Pharmaceutical Co., Ltd - April 08, 2025

Viwit Pharmaceutical Co., Ltd, a manufacturer of sterile drugs and contract laboratory in Zaozhuang, China, was inspected and cited for significant deficiencies across its quality, production, and laboratory systems. Observations included inadequate documentation of production procedures, failure to thoroughly investigate out-of-specification results, and critical deficiencies in aseptic processing and microbiological contamination prevention. These issues indicate a lack of control over sterile drug manufacturing processes.