FDA Inspection
Frontier Medical Products Inc.Frontier Medical Products Inc. – FDA Inspection, Jan 10, 2013
Record Details
This FDA Inspection record concerns Frontier Medical Products Inc., with an inspection on January 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 10, 2013
- Product Type
- Devices
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ID · dfb4ac5b-feca-4ef4-9e87-39755d85c686
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 813497
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of Frontier Medical Products Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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