FDA Inspection
Amrex Zetron IncAmrex Zetron Inc – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Amrex Zetron Inc, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6cf920ae-d872-49cb-84fd-cae04eac9010
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230398
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 820.184DHR content
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
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Other FDA inspections of Amrex Zetron Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2008 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Amrex Zetron Inc
- FDA Inspection 1040787 - 2018-01-17
- FDA Inspection 652380 - 2010-03-16
- FDA Inspection 544331 - 2008-11-03
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