FDA Inspection 1146184 — The Mentholatum Company
The FDA completed an inspection of The Mentholatum Company on June 17, 2021 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
- June 17, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orchard Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 8938 | FDCA 760(c)(1) | Timing of AE report submission (non-RX drugs) |