# FDA 483 - Hubei Biocause Heilen Pharmaceutical Co., Ltd. - November 14, 2025

Source: https://www.keypedia.com/records/483/hubei-biocause-heilen-pharmaceutical-co-ltd/d315b3a5-5ab7-476c-88e7-9b501e7eaf43

> FDA 483 for Hubei Biocause Heilen Pharmaceutical Co., Ltd. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei Biocause Heilen Pharmaceutical Co., Ltd.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hubei Biocause Heilen Pharmaceutical Co., Ltd. in Jingmen, China, received a Form FDA 483 with four observations during an inspection from November 10-14, 2025. The firm was cited for inadequate maintenance of API manufacturing equipment, insufficient evaluation of cleaning effectiveness, deficient system performance qualification, and failure to adequately evaluate drug product testing instruments. These findings highlight significant concerns regarding the firm's control over its manufacturing processes and quality systems for Active Pharmaceutical Ingredients.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/hubei-biocause-heilen-pharmaceutical-co-ltd/d226a8c2-7a18-4274-9541-ca7f8b4f84c0

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