FDA Inspection
United Products & Instruments, Inc. (d.b.a. UNICO)United Products & Instruments, Inc. (d.b.a. UNICO) – FDA Inspection, May 23, 2017
Record Details
This FDA Inspection record concerns United Products & Instruments, Inc. (d.b.a. UNICO), with an inspection on May 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2017
- Product Type
- Devices
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ID · 07c1d0e0-24e1-4d6d-a7fe-6d703daca7d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of United Products & Instruments, Inc. (d.b.a. UNICO)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 22, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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