Nowcos Co., Ltd – FDA 483, Jun 19, 2026

Nowcos Co., Ltd., a manufacturer in Sejong, Korea, was cited for significant deficiencies across six observations during an FDA inspection. Key issues include failures in quality control unit responsibilities, incomplete batch production records, inadequate material release procedures, unvalidated test methods, non-compliant stability testing, and insufficient equipment cleaning validation. Several observations are repeats from previous inspections in 2017 and 2019, indicating persistent non-compliance with CGMP regulations.