FDA Inspection
The Mentholatum CompanyThe Mentholatum Company – FDA Inspection, Jun 17, 2021
Record Details
This FDA Inspection record concerns The Mentholatum Company, with an inspection on June 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- The Mentholatum Company
- Inspection Date
- June 17, 2021
- Product Type
- Drugs
View Company Profile
ID · cb63ca47-be4e-4595-94e4-d4775357585f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1146184
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- Timing of AE report submission (non-RX drugs)
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.165(c)Sampling and testing plans not followed
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| April 26, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for The Mentholatum Company
- FDA Inspection 1283500 - 2026-03-23
- FDA Inspection 1231878 - 2024-03-27
- FDA Inspection 1132758 - 2020-10-27
- FDA Inspection 1095881 - 2019-07-09
- FDA Inspection 1009228 - 2017-04-26
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