# Huzhou Arthur Pharmaceutical Co., Ltd. – FDA 483, Sep 23, 2025

Source: https://www.keypedia.com/records/483/huzhou-arthur-pharmaceutical-co-ltd/c76e130a-39d0-4158-a268-c650f81904f2

> FDA 483 for Huzhou Arthur Pharmaceutical Co., Ltd. on September 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huzhou Arthur Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Huzhou Arthur Pharmaceutical Co., Ltd. in Huzhou, China, a manufacturer of sterile drugs, revealed significant deficiencies in their aseptic processing. Observations included inadequate validation of aseptic processes, ineffective cleaning and disinfection systems for aseptic areas, and shortcomings in environmental monitoring practices. These issues raise concerns about the prevention of microbiological contamination in sterile drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/huzhou-arthur-pharmaceutical-co-ltd/6bb5af56-f8a9-4b6b-883e-b70d30a47960

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