FDA Inspection 775386 — Belleview 402 LLC
The FDA completed an inspection of Belleview 402 LLC on March 30, 2012 in Brooksville, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |