FDA Inspection
Midbrook Inc.Midbrook Inc. – FDA Inspection, Nov 21, 2012
Record Details
This FDA Inspection record concerns Midbrook Inc., with an inspection on November 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Midbrook Inc.
- Inspection Date
- November 21, 2012
- Product Type
- Devices
View Company Profile
ID · f3606084-a6c2-4ad7-9510-10be7c0e5f12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809894
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.30(e)Design review - documentation
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Midbrook Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Midbrook Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.