# FDA 483 - Chinese Peptide Company - June 14, 2024

Source: https://www.keypedia.com/records/483/chinese-peptide-company/11d0bc90-18a7-4a33-87ce-a34b2432a96f

> FDA 483 for Chinese Peptide Company on June 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chinese Peptide Company
- Inspection Date: 2024-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2012-05-15](https://www.keypedia.com/records/warning_letter/chinese-peptide-company/8866b076-691b-4d23-9122-82ce222c254e)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1