715434
Maquet Cardiovascular, LLC — FEI 2242352
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 1, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |