Zhejiang Peptites Biotech Co.,Ltd. – FDA 483, Sep 7, 2023

This FDA Form 483 documents observations from an inspection, citing deficiencies in quality control and validation processes for active pharmaceutical ingredient (API) manufacturing.

**Observation 1** details the lack of adequate quality control for highly sensitizing materials in Workshop (b)(4). The firm has not established controls to prevent, detect, and control cross-contamination. Specific issues include: * Failure to follow the process validation program and absence of process validation for a specific API shipped to the USA market. * Manufacturing batch records for the API do not identify the manufacturing workshops, and employees could not agree on the location. * The cleaning validation procedure and risk assessment are not validated or adequately sound to ensure cross-contamination control in manufacturing workshops.

**Observation 2** highlights insufficient monitoring of utilities, specifically (b)(4). SOP-QA-QA 007, "Product Quality Review Management Procedure," requires testing for utility systems including (b)(4) and (b)(4). However, the firm lacks (b)(4) reports from 2019-2021 for (b)(4), which is used in API manufacturing.

Additionally, the firm lacks a scientifically sound cleaning validation program for APIs. A 2022 cleaning validation risk assessment for the workshop did not evaluate the most difficult to clean and highest risk product, despite the workshop using shared, non-dedicated equipment for API manufacturing.