# FDA 483 - Qingdao BAHEAL Pharmaceutical Co.,Ltd. - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/qingdao-baheal-pharmaceutical-coltd/649b06c7-96c4-4b54-bf43-9927c4343621

> FDA 483 for Qingdao BAHEAL Pharmaceutical Co.,Ltd. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qingdao BAHEAL Pharmaceutical Co.,Ltd.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Qingdao BAHEAL Pharmaceutical Co., Ltd., a drug manufacturer in Jimo, China, was cited for significant deficiencies during an FDA inspection from December 2-6, 2019. Observations included inadequate equipment cleaning and maintenance, insufficient written procedures for cleaning, incomplete batch production records, and critical failures in computer system controls leading to data integrity concerns. These issues indicate a lack of control over manufacturing processes and data, potentially impacting drug product quality and safety.

## Related Officers

- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/qingdao-baheal-pharmaceutical-coltd/c669eb8e-0a82-43e1-a4e2-a3b5db759fe7

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