FDA Inspection 607750 — Philips North America
The FDA completed an inspection of Philips North America on July 18, 2009 in Cambridge, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |