FDA Inspection
Braemar Manufacturing, LLCBraemar Manufacturing, LLC – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Braemar Manufacturing, LLC, with an inspection on November 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b31081e8-4291-4bf2-babd-2d9ca597ff01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030857
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Braemar Manufacturing, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Braemar Manufacturing, LLC
- FDA Inspection 819115 - 2013-02-20
- FDA Inspection 653191 - 2010-03-24
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