FDA Inspection 551807 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The FDA completed an inspection of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on Nov 20, 2008 in Best. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 20, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Best (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |