FDA 483 - Daewoo Pharmaceutical Co., Ltd. - January 15, 2025

Daewoo Pharmaceutical Co., Ltd. in Busan, Korea, received a Form 483 citing numerous deficiencies in their aseptic processing for sterile drug products. The inspection revealed inadequate validation of sterilization processes, poorly established procedures for preventing microbiological contamination, and significant issues with environmental monitoring and quality control oversight. These findings indicate critical concerns regarding the sterility assurance and overall quality management system for their drug products.