FDA Inspection 1201963 — Next Medical Products Company, LLC
The FDA completed an inspection of Next Medical Products Company, LLC on Apr 7, 2023 in Branchburg, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 7, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Branchburg, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |