FDA Inspection 1278082 — Derma Care Research Labs LLC
The FDA completed an inspection of Derma Care Research Labs LLC on August 8, 2025 in Daytona Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 8, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Daytona Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |