FDA Inspection 879394 — United Products & Instruments, Inc. (d.b.a. UNICO)
The FDA completed an inspection of United Products & Instruments, Inc. (d.b.a. UNICO) on May 22, 2014 in Dayton, NJ. 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
- May 22, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |