FDA Inspection 711251 — Noven Pharmaceuticals, Inc.
The FDA completed an inspection of Noven Pharmaceuticals, Inc. on February 14, 2011 in Carlsbad, CA. 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
- February 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |