932660
Philips North America, LLC — FEI 1218950
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |