Hubei Gedian Humanwell Pharmaceutical Co., Ltd.June 28, 2019

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

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Record Details

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.

Company: Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Inspection Date: June 28, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Uttaniti Limchumroon

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ID · 8323be85-4af9-4341-a1a0-af4396f4e8d1