FDA Inspection 1287088 — Hill Dermaceuticals, Inc.
The FDA completed an inspection of Hill Dermaceuticals, Inc. on Oct 14, 2025 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 14, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 23276 | FDCA 582(g)(1)(C) | Enhanced systems - verification |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |