CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003
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 letter is available in PDF at the bottom of this page.
FOOD AND DRUG ADMINISTRATION
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
60 8th Street, NE
Atlanta, Georgia 30309
DATE(S) OF INSPECTION
10/9/03, 10/10/03, 10/14/03
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Thomas J. Lynch, Vice President, Regulatory Affairs & Quality Assurance
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.
SEE REVERSE OF THIS PAGE
Leslie W. Gilbert
Vincent M. Williams
EMPLOYEE(S) NAME AND TITLE (Print or Type)
Leslie W. Gilbert, Investigator
Vincent M. Williams, Supervisory Investigator
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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."