FDA Inspection
Phraxis, Inc.Phraxis, Inc. – FDA Inspection, Jun 6, 2018
Record Details
This FDA Inspection record concerns Phraxis, Inc., with an inspection on June 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c90fd1bd-8420-4dfa-adac-76d814c1962e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054501
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.43(b)Sponsor shipped devices to unqualified person(s)
- 21 CFR 812.40Sponsors' general responsibilities
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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 | |
| August 20, 2019 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Phraxis, Inc.
- FDA Inspection 1257959 - 2024-12-18
- FDA Inspection 1254739 - 2024-10-31
- FDA Inspection 1099955 - 2019-08-20
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