CryoLife, Inc.
FDA inspection history in Kennesaw, Georgia, 2002 to 2015
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2002: one warning letter; 2003: one Form 483; 2015: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2002–03One warning letter and one Form 483, at Kennesaw, Georgia.
- 2015One close-out letter, at Kennesaw, Georgia.
Cited most
Across all CryoLife observations on file
- 21 CFR 1271.200Equipment2
- 21 CFR 1271.320Complaint file1
- 21 CFR 820.100Corrective and preventive action1
The complete CryoLife 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
Kennesaw, Georgia
One close-out letter and one Form 483 · 2003 to 2015 · 7 observations
Latest: Close-out, Apr 23, 2015 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-04-23 | Close-out Close-out letter | Kennesaw, Georgia | — | $99 |
| 2003-02-14 | 483 Form 483 | Kennesaw, Georgia | 7 | $99 |
| 2002-06-17 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Claudette D. Brooks (1)Karen A. Coleman (1)Mary Alice Papadimitriou (1)Paul A. Bonneau (1)
FEI number 3001451326 · most recent document Apr 23, 2015
About CryoLife, Inc.
How many FDA Form 483s has CryoLife, Inc. received?
FDA Intel has 1 Form 483 on file for CryoLife, Inc.; the most recent is dated Feb 14, 2003.
When was CryoLife, Inc. last inspected by FDA?
The most recent FDA inspection document on file for CryoLife, Inc. is a Form 483 dated Feb 14, 2003, for the site in Kennesaw, Georgia.
What did FDA cite at CryoLife, Inc.?
The regulations cited most in the observations on file for CryoLife, Inc. are 21 CFR 1271.200 (Equipment), 2 times; 21 CFR 1271.320 (Complaint file), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time.
Has CryoLife, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CryoLife, Inc.; the most recent is dated Jun 17, 2002.