FDA Inspection 773087 — Bracco Diagnostics, Inc.
The FDA completed an inspection of Bracco Diagnostics, Inc. on March 8, 2012 in Princeton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Princeton, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7557 | 21 CFR 312.56(b) | Notification of FDA of termination of investigator |