# FDA 483 - Zhejiang Dingtai Pharmaceutical Co., Ltd - February 28, 2025

Source: https://www.keypedia.com/records/483/zhejiang-dingtai-pharmaceutical-co-ltd/c42b49e1-6f7e-47c3-96a1-45ba7b7f9267

> FDA 483 for Zhejiang Dingtai Pharmaceutical Co., Ltd on February 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Dingtai Pharmaceutical Co., Ltd
- Inspection Date: 2025-02-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Zhejiang Dingtai Pharmaceutical Co., Ltd, a manufacturer of OTC drug products, revealed three significant observations. The firm was cited for inadequate laboratory controls, specifically regarding microbiological media preparation and testing, and for insufficient control procedures for manufacturing processes. Additionally, the inspection found a lack of detailed written procedures for the sampling, testing, approval, and rejection of components.

## Related Documents

- [483 - 2019-01-25](https://www.keypedia.com/records/483/zhejiang-dingtai-pharmaceutical-co-ltd/a04d3fcf-f0ad-4915-b2b4-cffe0ad15da7)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/zhejiang-dingtai-pharmaceutical-co-ltd/5ad59204-cae0-40c4-89df-50126877724c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8