FDA Inspection 888857 — Bracco Diagnostics, Inc.
The FDA completed an inspection of Bracco Diagnostics, Inc. on May 30, 2014 in Princeton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 30, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |