FDA Inspection 544396 — Novum Medical Products of NY, LLC
The FDA completed an inspection of Novum Medical Products of NY, LLC on October 10, 2008 in Amherst, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 10, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Amherst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |