FDA Inspection 682310 — Philips Medizin Systeme Boeblingen Gmbh
The FDA completed an inspection of Philips Medizin Systeme Boeblingen Gmbh on Sep 23, 2010 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boblingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |