# FDA 483 - Stella Chemifa Corporation - September 22, 2023

Source: https://www.keypedia.com/records/483/stella-chemifa-corporation/01208ca5-688a-42b2-b79e-887e8bfc0ee2

> FDA 483 for Stella Chemifa Corporation on September 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stella Chemifa Corporation
- Inspection Date: 2023-09-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Stella Chemifa Corporation, an API manufacturer in Izumiotsu City, Osaka, Japan, was cited for deficiencies during an FDA inspection. The observations primarily concern an inadequate accelerated stability program, including issues with sample container materials and delayed sample analysis. Additionally, the firm failed to ensure scientifically sound test procedures for API analysis, leading to impurity accumulation and affecting product quality and purity.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Mathematical statistician](https://www.keypedia.com/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.keypedia.com/companies/stella-chemifa-corporation/12643e4b-9b08-4e73-b5e8-e1f47cc5cf6f

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