FDA 483 - Chinese Peptide Company - June 14, 2024

An FDA inspection conducted from June 10-14, 2024, at Chinese Peptide Company, an Active Pharmaceutical Ingredient (API) manufacturer located in Hangzhou, Zhejiang, China, identified significant quality system deficiencies. The Form FDA 483 documented two main observations. Firstly, the company lacked established written procedures to ensure effective and reproducible manufacturing processes for APIs intended for the U.S. market. Specific issues included unvalidated (b)(4) processes where critical (b)(4) content analysis was omitted, an absence of acceptable criteria for evaluating intra-batch and inter-batch variability (leading to high variability), and inadequate sampling plans. Secondly, critical manufacturing equipment, such as a (b)(4) (ID 2021121703) used for (b)(4) processes, was not adequately qualified to perform as intended. This non-qualified equipment, whose operational and performance qualifications were deficient (e.g., ran without certain components), was nevertheless used to manufacture and ship APIs to the U.S. market, resulting in documented high batch variability. To achieve regulatory compliance, the company is required to implement comprehensive corrective actions, including establishing robust process validation procedures, defining clear acceptance criteria, ensuring adequate sampling, and fully qualifying all critical manufacturing equipment.