# FDA 483 - Zhejiang Peptites Biotech Co.,Ltd. - September 07, 2023

Source: https://www.keypedia.com/records/483/zhejiang-peptites-biotech-coltd/5f47854e-d668-4762-8669-c422df292e8e

> FDA 483 for Zhejiang Peptites Biotech Co.,Ltd. on September 07, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Peptites Biotech Co.,Ltd.
- Inspection Date: 2023-09-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

## Related Documents

- [483 - 2023-09-07](https://www.keypedia.com/records/483/zhejiang-peptites-biotech-coltd/b7a6f127-b094-438b-b350-8b4018b9f4b3)

Company: https://www.keypedia.com/companies/zhejiang-peptites-biotech-coltd/e2ec39f6-5557-4a89-bf23-65edb9d36a4e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c