FDA Inspection
Medical Digital Developers LLCMedical Digital Developers LLC – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Medical Digital Developers LLC, with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 19, 2009
- Product Type
- Devices
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ID · 56609263-9180-4fcc-9efa-4461f1507fc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628189
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)General
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Medical Digital Developers LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Digital Developers LLC
- FDA Inspection 886701 - 2014-07-01
- FDA Inspection 767799 - 2012-02-13
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