FDA Inspection 860927 — SmartScience Laboratories, Inc.
The FDA completed an inspection of SmartScience Laboratories, Inc. on Dec 6, 2013 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |