FDA Inspection
Medro Systems, IncMedro Systems, Inc – FDA Inspection, Jun 4, 2010
Record Details
This FDA Inspection record concerns Medro Systems, Inc, with an inspection on June 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medro Systems, Inc
- Inspection Date
- June 4, 2010
- Product Type
- Devices
View Company Profile
ID · 7701e221-bdd0-4a84-8c11-bab6340a177c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666928
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Medro Systems, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medro Systems, Inc
- FDA Inspection 811185 - 2012-12-18
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