891846
Elite Medical Supply of New York, LLC — FEI 3009513563
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Seneca, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |