FDA Inspection 1195599 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The FDA completed an inspection of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on January 26, 2023 in Best. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Best (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |