FDA Inspection
Temrex CorporationTemrex Corporation – FDA Inspection, Apr 15, 2010
Record Details
This FDA Inspection record concerns Temrex Corporation, with an inspection on April 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Temrex Corporation
- Inspection Date
- April 15, 2010
- Product Type
- Devices
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ID · e6570bcd-4139-45c0-8427-fc032efe2540
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657205
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Temrex Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| June 25, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 21, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 7, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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