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483
•Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.•May 19, 2017

Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. – FDA 483, May 19, 2017

Record Details

An FDA inspection of Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. revealed significant deficiencies in the manufacturing of Piyanping 1% Hydrocortisone Lotion. Key issues included product mislabeling, with the lotion containing Dexamethasone instead of Hydrocortisone, and a lack of essential quality control testing. The firm also failed to maintain adequate facility hygiene, proper recall procedures, equipment qualification, and complete batch records.

Company
Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.
Inspection date
May 19, 2017
Product type
drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Andrew J. Idzior (Investigator)
View Company Profile

ID · 3d7362d5-e071-43f2-bf6b-fda5504bb5ee

Other documents for Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.
  • WARNING_LETTER - 2017-05-19May 19, 2017

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