FDA Inspection 1156275 — Proactive Medical Products, LLC
The FDA completed an inspection of Proactive Medical Products, LLC on November 9, 2021 in Mount Vernon, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mount Vernon, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |