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483
•Mentholatum (China) Pharmaceuticals Co., Ltd.•June 21, 2019

Mentholatum (China) Pharmaceuticals Co., Ltd. – FDA 483, Jun 21, 2019

Record Details

Mentholatum (China) Pharmaceuticals Co., Ltd. in Zhongshan, China, a drug manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate laboratory controls, specifically concerning method verification for an assay, and a failure to thoroughly review unexplained discrepancies. These issues indicate deficiencies in quality control and assurance processes.

Company
Mentholatum (China) Pharmaceuticals Co., Ltd.
Inspection date
June 21, 2019
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Uttaniti Limchumroon
View Company Profile

ID · c6230b07-ca0e-408b-a880-ccedbabc8711

Other documents for Mentholatum (China) Pharmaceuticals Co., Ltd.
  • EIR - 2019-06-21June 21, 2019

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