FDA Inspection
Organ Recovery Systems, Inc.Organ Recovery Systems, Inc. – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Organ Recovery Systems, Inc., with an inspection on February 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3b6952c-8089-43da-972f-72450094d6e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001720
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Organ Recovery Systems, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Organ Recovery Systems, Inc.
- FDA Inspection 1071339 - 2018-10-16
- FDA Inspection 921541 - 2015-04-07
- FDA Inspection 752701 - 2011-11-08
- FDA Inspection 634996 - 2009-12-09
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