# FDA 483 - Xinyu Pharmaceutical Co., Ltd. - June 27, 2025

Source: https://www.globalkeysolutions.net/records/483/xinyu-pharmaceutical-co-ltd/93161494-c852-4989-b601-9734af6bdd03

> FDA 483 for Xinyu Pharmaceutical Co., Ltd. on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xinyu Pharmaceutical Co., Ltd.
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Jinyu Pharmaceutical Co., Ltd. in Suzhou, China, an API manufacturer, was inspected by the FDA from June 23-27, 2025. The inspection revealed significant deficiencies in quality assurance oversight, equipment identification and maintenance, and stability sample management. These issues indicate a lack of robust quality system controls for API manufacturing.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.globalkeysolutions.net/companies/xinyu-pharmaceutical-co-ltd/f603cb84-26a5-448f-9d9d-c25547afa6b7

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