FDA Inspection 994818 — Maquet Medical Systems USA
The FDA completed an inspection of Maquet Medical Systems USA on September 29, 2016 in Wayne, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |