FDA Inspection 1234657 — Active Intelligence LLC
The FDA completed an inspection of Active Intelligence LLC on March 8, 2024 in Cherryville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cherryville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |