FDA Inspection 1112801 — NextPhase Medical Devices LLC
The FDA completed an inspection of NextPhase Medical Devices LLC on December 13, 2019 in Mansfield, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mansfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |