Company
United StatesBreg, Inc, Grand Prairie, TX – FDA Inspections
Inspection records and compliance data for Breg, Inc in Grand Prairie, Texas. 2 FDA inspections on record, last inspected December 07, 2011.
Company Profile
This profile covers Breg, Inc based in Grand Prairie, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected May 27, 2010. Last inspected December 7, 2011.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Training records2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 7, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 756912 |
| May 27, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 659484 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Breg, Inc
FEI Number
1640542
Address
2601 Pinewood Dr, Grand Prairie, Texas 75051, United States
Country
United States
ID: 94c07848-dda1-459b-81d6-fee7cedc1c48