FDA Inspection
Organ Recovery Systems, Inc.Organ Recovery Systems, Inc. – FDA Inspection, Aug 7, 2026
Record Details
This FDA Inspection record concerns Organ Recovery Systems, Inc., with an inspection on August 7, 2026, issued by the Chicago District Office, covering medical devices & rad health.
- Company
- Organ Recovery Systems, Inc.
- Inspection Date
- August 7, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 85ac9bfd-1031-4ff0-8c2c-e622cce8277d
Inspection Facts
- Inspection number
- 1329854
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.25(e)Sponsor's lack of written monitoring procedures
- 21 CFR 812.35(a)(1)No approval for changes requiring prior approval
- 21 CFR 812.46(a)Sponsor securing investigator compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Organ Recovery Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2017 | OAI | 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 1001720 - 2017-02-10
- FDA Inspection 921541 - 2015-04-07
- FDA Inspection 752701 - 2011-11-08
- FDA Inspection 634996 - 2009-12-09
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