569821
Philips North America, LLC — FEI 1218950
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |