FDA Inspection 989300 — Angelini Pharma, Inc.
The FDA completed an inspection of Angelini Pharma, Inc. on September 2, 2016 in Atlanta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |