FDA Inspection 874869 — 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). 3 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 |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |