FDA 483 - Chinese Peptide Company - February 03, 2026

The FDA inspection of Chinese Peptide Company in Hangzhou, China, revealed significant deficiencies in its drug substance manufacturing operations. Key issues included inadequate contamination prevention measures, compromised data integrity in electronic systems, and critical process equipment not maintained in a validated state. The firm also failed to maintain complete batch production records and adhere to or adequately define standard operating procedures, indicating systemic quality control failures.