Organ Recovery Systems, Inc
FDA inspection history in Itasca, Illinois, 2017 to 2018
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2017: one warning letter and one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One warning letter, one Form 483 and one close-out letter, at Itasca, Illinois.
Cited most
Across all Organ Recovery Systems observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.160(a)Distribution1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.75(a)Process validation1
The complete Organ Recovery Systems file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Itasca, Illinois
One close-out letter, one warning letter and one Form 483 · 2017 to 2018 · 5 observations
Latest: Close-out, Nov 28, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-28 | Close-out Close-out letter | Itasca, Illinois | — | $99 |
| 2017-04-20 | Warning letter Warning letter | Itasca, Illinois | — | $99 |
| 2017-02-10 | 483 Form 483 | Itasca, Illinois | 5 | $99 |
Investigators on these documents
FEI number 3004068499 · most recent document Nov 28, 2018
About Organ Recovery Systems, Inc
How many FDA Form 483s has Organ Recovery Systems, Inc received?
FDA Intel has 1 Form 483 on file for Organ Recovery Systems, Inc; the most recent is dated Feb 10, 2017.
When was Organ Recovery Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Organ Recovery Systems, Inc is a Form 483 dated Feb 10, 2017, for the site in Itasca, Illinois.
What did FDA cite at Organ Recovery Systems, Inc?
The regulations cited most in the observations on file for Organ Recovery Systems, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.160(a) (Distribution), 1 time; 21 CFR 820.30(g) (Design controls), 1 time.
Has Organ Recovery Systems, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Organ Recovery Systems, Inc; the most recent is dated Apr 20, 2017.