FDA Inspection 792085 — Bracco Diagnostics, Inc.
The FDA completed an inspection of Bracco Diagnostics, Inc. on July 27, 2012 in Princeton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17913 | 21 CFR 212.100(a) | Written complaint procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |