FDA Inspection
UCP Bioscience IncUCP Bioscience Inc – FDA Inspection, Nov 18, 2024
Record Details
This FDA Inspection record concerns UCP Bioscience Inc, with an inspection on November 18, 2024, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · 2b4ec999-23a4-4123-8f39-c0ef80630f37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255858
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UCP Bioscience Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2017 | Not classified | San Francisco District Office | |
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for UCP Bioscience Inc
- FDA Inspection 1006634 - 2017-03-17
- FDA Inspection 895292 - 2014-09-12
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