# FDA 483 - Chinese Peptide Company - February 03, 2026

Source: https://www.keypedia.com/records/483/chinese-peptide-company/8b25265a-62fd-4a9d-ac70-a5bfb411cd4b

> FDA 483 for Chinese Peptide Company on February 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chinese Peptide Company
- Inspection Date: 2026-02-03
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

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## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Biologist](https://www.keypedia.com/people/jacek-cieslak/59683a5f-277f-41b8-be10-0dc82b7596f3)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/chinese-peptide-company/ba8c6a32-f679-405b-bb0a-e82713b7cb62

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4