FDA 483 - Chinese Peptide Company - June 14, 2024

The FDA inspected Chinese Peptide Company in Hangzhou, China, and issued two observations. The inspection revealed significant deficiencies in process validation for Active Pharmaceutical Ingredients (APIs) manufactured for the US market, including a lack of established procedures, inadequate sampling plans, and uninvestigated batch variability. Additionally, critical manufacturing equipment was found to be inadequately qualified, leading to the use of non-qualified equipment for APIs shipped to the US.