FDA Inspection
Breg, IncBreg, Inc – FDA Inspection, Dec 7, 2011
Record Details
This FDA Inspection record concerns Breg, Inc, with an inspection on December 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Breg, Inc
- Inspection Date
- December 7, 2011
- Product Type
- Devices
View Company Profile
ID · 87c95386-72c1-4d82-93eb-7fc2a831f1c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756912
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Breg, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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