FDA Inspection
Medical Device Resource CorporationMedical Device Resource Corporation – FDA Inspection, May 6, 2013
Record Details
This FDA Inspection record concerns Medical Device Resource Corporation, with an inspection on May 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 6, 2013
- Product Type
- Devices
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ID · f765e70e-a2c5-4ffa-ba45-4b56d36828f8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 830915
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
18- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 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(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - 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
Showing 10 of 18 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 |
| July 14, 2014 | VAI | Center for Devices and Radiological Health | Compliance: 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 887300 - 2014-07-14
- FDA Inspection 776342 - 2012-04-09
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