FDA Inspection
Bio-Research Associates Inc.Bio-Research Associates Inc. – FDA Inspection, Mar 21, 2018
Record Details
This FDA Inspection record concerns Bio-Research Associates Inc., with an inspection on March 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 130fed47-0e91-42d1-958b-19ef1d0b1bb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046081
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Bio-Research Associates Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio-Research Associates Inc.
- FDA Inspection 923842 - 2015-04-23
- FDA Inspection 626246 - 2009-11-13
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