FDA Inspection
Polymerex Medical CorpPolymerex Medical Corp – FDA Inspection, Sep 23, 2019
Record Details
This FDA Inspection record concerns Polymerex Medical Corp, with an inspection on September 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1b2ce6d6-32d6-4447-91c4-e4ba257a5930
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102645
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Polymerex Medical Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Polymerex Medical Corp
- FDA Inspection 940946 - 2015-08-26
- FDA Inspection 841496 - 2013-07-24
- FDA Inspection 697313 - 2010-11-04
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