FDA Inspection 1254861 — SmartScience Laboratories, Inc.
The FDA completed an inspection of SmartScience Laboratories, Inc. on November 22, 2024 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 22, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |