FDA Inspection 702476 — Belleview 402 LLC
The FDA completed an inspection of Belleview 402 LLC on November 24, 2010 in Brooksville, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 24, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |