# FDA 483 - Zhejiang Ausun Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/zhejiang-ausun-pharmaceutical-co-ltd/7a736a57-1966-4751-8518-e6514b89469c

> FDA 483 for Zhejiang Ausun Pharmaceutical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Ausun Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Zhejiang Ausun Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient manufacturer in Zhejiang, China, revealed three observations. The findings primarily concern discrepancies in critical process parameter results, inadequate error correction procedures for controlled documents, and a lack of calibrated clocks in areas where time entries are made into batch production records. These issues indicate deficiencies in data integrity and quality control practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-r-goga/86a76251-51c6-461a-b2f3-abbfbdb8ec3b)

Company: https://www.globalkeysolutions.net/companies/zhejiang-ausun-pharmaceutical-co-ltd/5c30ecf3-fdd1-4d64-833f-d28cc43b3da4

Office: https://www.globalkeysolutions.net/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591