FDA Inspection 1017694 — United Products & Instruments, Inc. (d.b.a. UNICO)
The FDA completed an inspection of United Products & Instruments, Inc. (d.b.a. UNICO) on May 23, 2017 in Dayton, NJ. 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
- May 23, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |