FDA Inspection
Rex Medical LPRex Medical LP – FDA Inspection, Apr 19, 2017
Record Details
This FDA Inspection record concerns Rex Medical LP, with an inspection on April 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d5ef590d-d2b9-4b5c-9f66-62a1ac734259
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014186
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.70(g)(2)Periodic equipment inspections
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Other FDA inspections of Rex Medical LP
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rex Medical LP
- FDA Inspection 946070 - 2015-10-23
- FDA Inspection 760520 - 2011-12-16
- FDA Inspection 614705 - 2009-08-31
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