Company
United StatesThe Mentholatum Company, Orchard Park, NY – FDA Inspections
Inspection records and compliance data for The Mentholatum Company in Orchard Park, New York. 12 FDA inspections on record, 2 Form 483s, last inspected March 23, 2026.
Company Profile
This profile covers The Mentholatum Company based in Orchard Park, New York, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 5
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 11, 2009. Last inspected March 23, 2026.
Most cited issue areas
- Acceptance of drug products1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Failure of responsible person to report AE (non-RX Drug)1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 23, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1283500 |
| March 27, 2024 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1231878 |
| June 17, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1146184 |
| October 27, 2020 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 1132758 |
| July 9, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1095881 |
| April 26, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1009228 |
| May 27, 2016 | VAI | Human Drugs · Drug Quality Assurance | 983260 |
| December 6, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 859385 |
| February 20, 2013 | VAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 820085 |
| December 6, 2010 | VAI | Human Drugs · Drug Quality Assurance | 702276 |
| November 13, 2009 | NAI | Human Drugs · Drug Quality Assurance | 628967 |
| August 11, 2009 | NAI | Human Drugs · Drug Quality Assurance | 603569 |
FDA documents
Form 483s (2)
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Company Information
Name
The Mentholatum Company
FEI Number
3000717606
Address
707 Sterling Dr, Orchard Park, New York 14127, United States
Country
United States
ID: b6fe9a36-3f40-411d-82b1-1c00b610492f