# FDA 483 - Pharmaron Shaoxing Co., Ltd. - June 04, 2025

Source: https://www.keypedia.com/records/483/pharmaron-shaoxing-co-ltd/543df91f-f20e-47b9-8b8a-1b7c422d5f05

> FDA 483 for Pharmaron Shaoxing Co., Ltd. on June 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaron Shaoxing Co., Ltd.
- Inspection Date: 2025-06-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pharmaron Shaoxing Co., Ltd. in Shaoxing, China, revealed significant deficiencies in their quality control systems for API manufacturing. The firm failed to conduct adequate investigations into out-of-specification results, lacking sufficient evidence for root cause determination. Additionally, the company did not maintain proper backup files for computerized system data and lacked records for the cleaning and maintenance of manufacturing equipment.

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/pharmaron-shaoxing-co-ltd/d35f3e31-09cc-4795-9bd4-98e480681b9a

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