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

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

Record Details

This FDA Inspection record concerns Mentholatum (China) Pharmaceuticals Co., Ltd., with an inspection on June 21, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mentholatum (China) Pharmaceuticals Co., Ltd.
Inspection Date
June 21, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Uttaniti Limchumroon (FDA Associated Person)
View Company Profile

ID · edb8099b-0ac9-4093-af8b-f9d7551326f7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1096085
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mentholatum (China) Pharmaceuticals Co., Ltd.

2
DateClassificationOfficeProject area
August 15, 2025Not classifiedOffice of Inspections and Investigations
April 10, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mentholatum (China) Pharmaceuticals Co., Ltd.
  • FDA Inspection 1281942 - 2025-08-15
  • FDA Inspection 926688 - 2015-04-10

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