Organ Recovery Systems, Inc
Form 483 issued February 10, 2017 · Itasca, Illinois
- Inspection
- Jan 17 – Feb 10, 2017
- Investigators
- David Gasparovich· Maksim A. Levenchuk
- Observations
- 5
- Pages
- 4
- FEI number
- 3004068499
In short: On February 10, 2017, FDA issued a Form 483 with 5 observations to Organ Recovery Systems, Inc in Itasca, Illinois (FEI 3004068499) after an inspection that ran Jan 17 – Feb 10, 2017. The investigators were David Gasparovich and Maksim A. Levenchuk. Most observations concern production & process controls and design controls.
At a glance
3 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
The results of design validation, including identification of the design, method(s), the date and the individual(s)…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for control and distribution of finished devices…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmOrgan Recovery Systems, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Organ Recovery Systems, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Organ Recovery Systems, Inc?
David Gasparovich and Maksim A. Levenchuk are named on this Form 483, for the inspection of Jan 17 – Feb 10, 2017. Each investigator has a profile showing what they cite most.
When was Organ Recovery Systems, Inc inspected by FDA?
The inspection ran Jan 17 – Feb 10, 2017, and the Form 483 is dated February 10, 2017.
How do I get the full Form 483 for Organ Recovery Systems, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.