FDA Inspection
Medical Device Resource CorporationMedical Device Resource Corporation – FDA Inspection, Jul 14, 2014
Record Details
This FDA Inspection record concerns Medical Device Resource Corporation, with an inspection on July 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 14, 2014
- Product Type
- Devices
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ID · f5a487e0-5bb1-4819-98c2-7d3c1bf2b5d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Showing 10 of 16 citations.
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Other FDA inspections of Medical Device Resource Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 9, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Device Resource Corporation
- FDA Inspection 1044567 - 2018-02-16
- FDA Inspection 830915 - 2013-05-06
- FDA Inspection 776342 - 2012-04-09
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