# Yangzhou Aurisco Pharmaceutical Co.,Ltd. – FDA 483, Jun 19, 2026

Source: https://www.keypedia.com/records/483/yangzhou-aurisco-pharmaceutical-coltd/080d4781-61f6-48df-a817-ceb1630204ca

> FDA 483 for Yangzhou Aurisco Pharmaceutical Co.,Ltd. on June 19, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yangzhou Aurisco Pharmaceutical Co.,Ltd.
- Inspection Date: 2026-06-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Yangzhou Aurisco Pharmaceutical Co., Ltd. in Yangzhou, China, an API manufacturer, revealed significant deficiencies in their quality control and manufacturing processes. The firm failed to adequately establish and follow procedures to assure drug substance identity, strength, quality, and purity, specifically regarding stability studies and testing. Furthermore, the inspection found a lack of adequate statistical methods for process validation and a failure to identify and document Critical Quality Attributes and Critical Process Parameters for API manufacturing.

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.keypedia.com/companies/yangzhou-aurisco-pharmaceutical-coltd/0ea3dfec-2357-4631-9b23-a9c72c73098b

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