Company
United StatesMedro Systems, Inc, McKinney, TX – FDA Inspections
Inspection records and compliance data for Medro Systems, Inc in McKinney, Texas. 2 FDA inspections on record, last inspected December 18, 2012.
Company Profile
This profile covers Medro Systems, Inc based in McKinney, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 4, 2010. Last inspected December 18, 2012.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 811185 |
| June 4, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 666928 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medro Systems, Inc
FEI Number
1641306
Address
416 Industrial Blvd, McKinney, Texas 75069, United States
Country
United States
ID: bae2b862-710a-4b33-bc06-780a3c8b5453