FDA Inspection 855744 — Novum Medical Products of NY, LLC
The FDA completed an inspection of Novum Medical Products of NY, LLC on November 15, 2013 in Amherst, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Amherst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |