FDA Inspection 1283500 — The Mentholatum Company
The FDA completed an inspection of The Mentholatum Company on March 23, 2026 in Orchard Park, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orchard Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |