FDA Inspection 1074298 — SmartScience Laboratories, Inc.
The FDA completed an inspection of SmartScience Laboratories, Inc. on Dec 10, 2018 in Tampa, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |