# FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - October 14, 2013

Source: https://www.globalkeysolutions.net/records/483/hubei-gedian-humanwell-pharmaceutical-co-ltd/a5cd9950-9dbd-4b96-8a36-3adfa63fef66

> FDA 483 for Hubei Gedian Humanwell Pharmaceutical Co., Ltd. on October 14, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
- Inspection Date: 2013-10-14
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd in Ezhou, China, revealed a significant quality system deficiency. The firm's Quality Unit failed to implement adequate controls to prevent adverse effects on API drug products during storage. Specifically, the monitoring system for critical parameters like temperature and humidity in the API warehouse lacked a backup system to ensure and confirm that deviations had not occurred and were fully investigated.

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## Related Officers

- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/hubei-gedian-humanwell-pharmaceutical-co-ltd/6e51acbd-3f42-46c6-ad1a-70822bdd7a88

Office: https://www.globalkeysolutions.net/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591