FDA Inspection 727431 — Sandoz Incorporated
The FDA completed an inspection of Sandoz Incorporated on May 6, 2011 in East Hanover, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 6, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Hanover, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |