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

Source: https://www.globalkeysolutions.net/records/483/pharmaron-shaoxing-co-ltd/9c14e715-0b3b-4d53-becf-75ae234b1ecf

> 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 Inspections and Investigations
- Summary: Pharmaron Shaoxing Co., Ltd., an API manufacturer in Shaoxing, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate Out of Specification investigations, failure to maintain backup files for computerized data, and insufficient cleaning records for manufacturing equipment. These issues indicate a lack of robust quality control and data integrity practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pharmaron-shaoxing-co-ltd/46e46053-2a60-4ce8-9f9f-b4fe235c95f9

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