FDA Inspection 607750 — Philips North America
The FDA completed an inspection of Philips North America on Jul 18, 2009 in Cambridge, MA. 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
- Jul 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |