FDA Inspection
Brain Research, Inc.Brain Research, Inc. – FDA Inspection, Sep 7, 2012
Record Details
This FDA Inspection record concerns Brain Research, Inc., with an inspection on September 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brain Research, Inc.
- Inspection Date
- September 7, 2012
- Product Type
- Devices
View Company Profile
ID · 65cc919b-9e83-4695-95bf-490257a62e80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796957
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Brain Research, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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