FDA Inspection 696817 — Innova SoftGel LLC
The FDA completed an inspection of Innova SoftGel LLC on November 17, 2010 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 945 | 21 CFR 123.12(a)(2) | Importer verification |