# FDA 483 - Qilu Pharmaceutical (Hainan) Co. Ltd. - November 06, 2019

Source: https://www.globalkeysolutions.net/records/483/qilu-pharmaceutical-hainan-co-ltd/723eae93-3a14-4608-bbf6-fb6e3f0a7637

> FDA 483 for Qilu Pharmaceutical (Hainan) Co. Ltd. on November 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical (Hainan) Co. Ltd.
- Inspection Date: 2019-11-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Qilu Pharmaceutical (Hainan) Co., Ltd., a sterile drug manufacturer, revealed multiple significant deficiencies. These included failures in following written procedures for visual inspection of in-process materials, inadequate investigations into unexplained discrepancies, and a lack of established or followed procedures to prevent microbiological contamination. Additionally, the firm failed to thoroughly review unexplained discrepancies and ensure the accuracy of computer system input and output, particularly concerning audit trails for filter integrity testing instruments.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/qilu-pharmaceutical-hainan-co-ltd/60dedaab-e32c-493a-894b-9eec7372c066

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