CryoLife, Inc.
Form 483 issued February 14, 2003 · Kennesaw, Georgia
- Inspection
- Feb 3 – Feb 14, 2003
- Investigators
- Claudette D. Brooks· Karen A. Coleman· Mary Alice Papadimitriou
- Observations
- 7
- Pages
- 3
- FEI number
- 3001451326
In short: On February 14, 2003, FDA issued a Form 483 with 7 observations to CryoLife, Inc. in Kennesaw, Georgia (FEI 3001451326) after an inspection that ran Feb 3 – Feb 14, 2003. The investigators were Claudette D. Brooks, Karen A. Coleman, Mary Alice Papadimitriou and Paul A. Bonneau. Most observations concern hCT/P and cAPA; the most-cited regulation is 21 CFR 1271.200 (equipment).
At a glance
6 of 7 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.200 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm did not retrieve allografts that are known to be associated with infections (processed prior…
- 02
The complaint handling system is deficient in that: A). The firm document and/or follow-up on a…
- 03
The firm’s bacteriostasis/fungistasis testing on the anti-microbial cocktail foregut…
- 04
The firm’s bioburden program…
This inspection in context
Claudette D. Brooks
6 documents · 2003–2018
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmCryoLife, 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 1271.200
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CryoLife, Inc.?
FDA listed 7 observations on this Form 483, mostly about hCT/P and cAPA. The most-cited regulation is 21 CFR 1271.200 (equipment). The opening words of each observation are shown on this page.
Who inspected CryoLife, Inc.?
Claudette D. Brooks, Karen A. Coleman, Mary Alice Papadimitriou and Paul A. Bonneau are named on this Form 483, for the inspection of Feb 3 – Feb 14, 2003. Each investigator has a profile showing what they cite most.
When was CryoLife, Inc. inspected by FDA?
The inspection ran Feb 3 – Feb 14, 2003, and the Form 483 is dated February 14, 2003.
How do I get the full Form 483 for CryoLife, 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.