FDA Inspection
Medical Positioning IncMedical Positioning Inc – FDA Inspection, Jan 11, 2011
Record Details
This FDA Inspection record concerns Medical Positioning Inc, with an inspection on January 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Positioning Inc
- Inspection Date
- January 11, 2011
- Product Type
- Devices
View Company Profile
ID · 4fc8afd9-5ada-43be-a71a-ad316a9e09ac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 706451
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Showing 10 of 12 citations.
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Other FDA inspections of Medical Positioning Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Positioning Inc
- FDA Inspection 810311 - 2012-12-12
- FDA Inspection 750289 - 2011-10-19
- FDA Inspection 598350 - 2009-07-22
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