# FDA 483 - Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory - March 07, 2025

Source: https://www.keypedia.com/records/483/zhejiang-medicine-co-ltd-xinchang-pharmaceutical-factory/e79ea251-4e9a-40d7-be71-6b1b29720a53

> FDA 483 for Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory, a human drug and API manufacturer in Xinchang, P.R. China, was inspected by the FDA. The inspection revealed that the firm's written stability program for drug substances is not stability indicating. This deficiency raises concerns about the assurance of analytical methods used to test drug substances for purity and the quality of products shipped to the U.S. market.

## Related Documents

- [483 - 2015-06-18](https://www.keypedia.com/records/483/zhejiang-medicine-co-ltd-xinchang-pharmaceutical-factory/56458423-b281-4593-9ae2-cbdef29b8eb0)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/zhejiang-medicine-co-ltd-xinchang-pharmaceutical-factory/e800486e-60a0-49f5-8d0b-02f5ce3f408c

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