FDA Inspection 874866 — Belleview 402 LLC
The FDA completed an inspection of Belleview 402 LLC on April 1, 2014 in Brooksville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |