FDA Inspection
Bio-Research Associates Inc.Bio-Research Associates Inc. – FDA Inspection, Nov 13, 2009
Record Details
This FDA Inspection record concerns Bio-Research Associates Inc., with an inspection on November 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio-Research Associates Inc.
- Inspection Date
- November 13, 2009
- Product Type
- Devices
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ID · 49bb328a-e7f6-4f8a-89e2-d9b75f8ce84a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.200(d)No Service reports
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Bio-Research Associates Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio-Research Associates Inc.
- FDA Inspection 1046081 - 2018-03-21
- FDA Inspection 923842 - 2015-04-23
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