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

Source: https://www.keypedia.com/records/483/zhejiang-peptites-biotech-coltd/b7a6f127-b094-438b-b350-8b4018b9f4b3

> 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: Office of Biological Products Operations - Division I
- Summary: Zhejiang Peptides Biotech Co., Ltd, an API manufacturer in Shaoxing, Zhejiang, was cited for significant deficiencies during an FDA inspection. Observations included inadequate quality control for highly sensitizing materials, failure to prevent cross-contamination, lack of process validation, and insufficient monitoring of utilities. The firm also lacked a scientifically sound cleaning validation program, particularly concerning shared equipment and high-risk products.

## Related Documents

- [483 - 2023-09-07](https://www.keypedia.com/records/483/zhejiang-peptites-biotech-coltd/5f47854e-d668-4762-8669-c422df292e8e)

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

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

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