759069
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |