# FDA 483 - Changzhou Tianhua Pharmaceutical Co., Ltd. - April 19, 2019

Source: https://www.keypedia.com/records/483/changzhou-tianhua-pharmaceutical-co-ltd/f59a9b59-98ec-463c-a86e-0fd56d23c0c5

> FDA 483 for Changzhou Tianhua Pharmaceutical Co., Ltd. on April 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Changzhou Tianhua Pharmaceutical Co., Ltd.
- Inspection Date: 2019-04-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Changzhou Tianhua Pharmaceutical Co., Ltd. in Jintan, Jiangsu, China, a manufacturer of intermediates and APIs, revealed significant deficiencies. Observations included inadequate personnel training, incomplete batch production records, and failures in equipment calibration and maintenance. The firm also lacked complete investigations for Out-Of-Specification results and proper written procedures for equipment cleaning.

## Related Officers

- [Saira A Asbyd](https://www.keypedia.com/people/saira-a-asbyd/cd053b27-1f73-4c2f-ad0e-5d7abb6c73f6)

Company: https://www.keypedia.com/companies/changzhou-tianhua-pharmaceutical-co-ltd/7ec1aae2-5e24-4a13-8fb3-887b3d19d027

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