FDA Inspection 853190 — Sandoz Incorporated
The FDA completed an inspection of Sandoz Incorporated on October 17, 2013 in East Hanover, NJ. 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
- October 17, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- East Hanover, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |