FDA Inspection
UROMATRIX Medical Systems (A Pos-T-Vac Medical Company)UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) – FDA Inspection, Jun 8, 2011
Record Details
This FDA Inspection record concerns UROMATRIX Medical Systems (A Pos-T-Vac Medical Company), with an inspection on June 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 8, 2011
- Product Type
- Devices
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ID · f17246dd-c132-4c12-9472-b7cb5d0b0850
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- 21 CFR 803.18(d)(1)Distributor"s device incident records
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Other FDA inspections of UROMATRIX Medical Systems (A Pos-T-Vac Medical Company)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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