FDA Inspection 791970 — Philips Medizin Systeme Boeblingen Gmbh
The FDA completed an inspection of Philips Medizin Systeme Boeblingen Gmbh on Jun 14, 2012 in Boblingen. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boblingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |