FDA Inspection
Midbrook Inc.Midbrook Inc. – FDA Inspection, Dec 22, 2014
Record Details
This FDA Inspection record concerns Midbrook Inc., with an inspection on December 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Midbrook Inc.
- Inspection Date
- December 22, 2014
- Product Type
- Devices
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ID · a4ce423a-d99e-479f-93e2-1d4d8e52e3fe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908040
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Showing 10 of 16 citations.
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Other FDA inspections of Midbrook Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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