915514
SunMed Holdings, LLC — FEI 1314417
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 2, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 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 |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |