875871
AGFA Healthcare Corp. — FEI 3001236302
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 11, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |