FDA Inspection 891846 — Elite Medical Supply of New York, LLC
The FDA completed an inspection of Elite Medical Supply of New York, LLC on August 14, 2014 in West Seneca, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
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 |