FDA Inspection
Phraxis, Inc.Phraxis, Inc. – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns Phraxis, Inc., with an inspection on August 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd7ff1d1-6e9b-4ef8-87e3-5976a0121799
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099955
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Phraxis, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | Not classified | Minneapolis District Office | |
| October 31, 2024 | Not classified | Minneapolis District Office | |
| June 6, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
Other documents for Phraxis, Inc.
- FDA Inspection 1257959 - 2024-12-18
- FDA Inspection 1254739 - 2024-10-31
- FDA Inspection 1054501 - 2018-06-06
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