# FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/hubei-gedian-humanwell-pharmaceutical-co-ltd/8323be85-4af9-4341-a1a0-af4396f4e8d1

> FDA 483 for Hubei Gedian Humanwell Pharmaceutical Co., Ltd. on June 28, 2019. 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: 2019-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China, from June 24-28, 2019, revealed significant deficiencies in equipment maintenance. The firm was cited for inadequate preventive maintenance of its (b)(4) tanks, specifically noting issues with loose plastic tape and old, worn-out seals. These observations indicate a lapse in quality control regarding the upkeep of critical manufacturing equipment.

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## Related Officers

- [Uttaniti Limchumroon](https://www.globalkeysolutions.net/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

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

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