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

Daewoo Pharmaceuticals Co., Ltd., located in Busan, South Korea, was inspected by the FDA from January 6 to 15, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 CFR parts 210 and 211. These violations render the drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key issues identified include:

1. **Inadequate Aseptic Processing**: The firm failed to establish and follow procedures to prevent microbiological contamination in sterile drug products. Smoke studies revealed turbulent airflow in critical areas, and media fills did not accurately simulate commercial operations, lacking representation of routine production interventions.

2. **Poor Aseptic Practices**: Observations included insufficient personnel monitoring and inadequate training for operators in ISO 5 areas, which compromised sterility assurance.

3. **Contamination Risks**: The design of the aseptic processing line was inadequate, with gaps affecting airflow and improper sterilization of equipment. Environmental monitoring lacked scientific justification, posing a contamination risk.

4. **Insufficient Production Controls**: The visual inspection process was inadequate, lacking proper defect identification and quality assurance measures.

The FDA requires Daewoo Pharmaceuticals to address these deficiencies by providing detailed corrective actions, including plans for redesigning the aseptic processing line, enhancing personnel training, and improving environmental and visual inspection protocols. Failure to adequately address these issues may result in regulatory actions, impacting the firm"s ability to market products in the U.S.