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Talk to a SpecialistTalk to a SpecialistDaewoo Pharmaceutical Co., Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of sterile drug products following an FDA inspection in January 2025. The company failed to establish and follow adequate written procedures to prevent microbiological contamination, specifically failing to validate aseptic and sterilization processes as required by regulation. Smoke studies revealed inadequate unidirectional airflow and turbulent conditions in the ISO 5 aseptic processing operation, and the company's proposed corrective actions were deemed insufficient due to lack of specific details regarding remediation and implementation timelines. The violations render the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.