# FDA 483 - Jiangsu Anbison Pharmaceutical Co., Ltd. - July 16, 2024

Source: https://www.keypedia.com/records/483/jiangsu-anbison-pharmaceutical-co-ltd/1f15e594-e0fe-4ce3-89a0-012e7b14b791

> FDA 483 for Jiangsu Anbison Pharmaceutical Co., Ltd. on July 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Anbison Pharmaceutical Co., Ltd.
- Inspection Date: 2024-07-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jiangsu Anbison Pharmaceutical Co., Ltd. in Taizhou, China, revealed significant deficiencies in their manufacturing operations. Observations included inadequate quality control unit procedures for reviewing audit trails, insufficient validation of aseptic processes for sterile drug products, and deficiencies in environmental monitoring within aseptic processing areas. These issues indicate a lack of control over critical manufacturing processes and data integrity.

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## Related Officers

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

Company: https://www.keypedia.com/companies/jiangsu-anbison-pharmaceutical-co-ltd/f9324a6c-1ec8-40eb-8148-73c13ea386df

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1