Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in  PDF format on this website. |
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DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
|
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
FDA
60 8th Street, NE
Atlanta, Georgia 30309 |
DATE(S)
OF INSPECTION
10/9/03, 10/10/03, 10/14/03
|
FEI
NUMBER
3001451326 |
NAME
AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Thomas
J. Lynch, Vice President, Regulatory Affairs & Quality Assurance |
FIRM NAME
CryoLife Inc. |
STREET ADDRESS
1655 Roberts Blvd. |
CITY, STATE
AND ZIP CODE
Kennesaw, Georgia 30144 |
TYPE OF
ESTABLISHMENT INSPECTED
Human Tissue Firm |
|
DURING AN INSPECTION OF YOUR FIRM, WE OBSERVED:
Failure to validate written procedures for prevention of infectious
disease contamination during processing. Specifically, the Anti-microbial
cocktail
which is sometimes referred to as Combo Cocktail Solution has not been
validated. The firm has not validated the processing operations/precedures
for decontaminating tissue.
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| SEE
REVERSE OF THIS PAGE |
EMPLOYEE(S)
SIGNATURE
[Signed]
Leslie W. Gilbert
Vincent M. Williams |
EMPLOYEE(S) NAME AND TITLE (Print or Type)
Leslie W. Gilbert,
Investigator
Vincent M. Williams, Supervisory Investigator
|
DATE ISSUED
10/14/03 |
FORM FDA 483 (8/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL
OBSERVATIONS
| Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
| Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: "Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary." |
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