Company
United StatesOrgan Recovery Systems, Inc., Itasca, IL – FDA Inspections
Inspection records and compliance data for Organ Recovery Systems, Inc. in Itasca, Illinois. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 16, 2018.
Company Profile
This profile covers Organ Recovery Systems, Inc. based in Itasca, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 9, 2009. Last inspected October 16, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 16, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1071339 |
| February 10, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1001720 |
| April 7, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 921541 |
| November 8, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752701 |
| December 9, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 634996 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Organ Recovery Systems, Inc.
FEI Number
3004068499
Address
1 Pierce Pl Ste 475w, Itasca, Illinois 60143, United States
Country
United States
ID: 4b4d6017-d63e-4130-b770-7367ff8b9b3c