FDA Inspection
The Mentholatum CompanyThe Mentholatum Company – FDA Inspection, May 27, 2016
Record Details
This FDA Inspection record concerns The Mentholatum Company, with an inspection on May 27, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- The Mentholatum Company
- Inspection Date
- May 27, 2016
- Product Type
- Drugs
View Company Profile
ID · 7bdfef59-895f-4fe2-b949-03892840a739
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983260
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of The Mentholatum Company
11| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| March 27, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2020 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 9, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for The Mentholatum Company
- FDA Inspection 1283500 - 2026-03-23
- FDA Inspection 1231878 - 2024-03-27
- FDA Inspection 1146184 - 2021-06-17
- FDA Inspection 1132758 - 2020-10-27
- FDA Inspection 1095881 - 2019-07-09
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