I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on October 02, 2007, 01:27:27 PM
-
FDA Finds Contamination Problems at French Genzyme Plant That Makes Kidney Transplant Drug
Matthew Perrone
October 2, 2007 - 11:33 a.m.
WASHINGTON (AP) - U.S. health regulators have warned biotech drug maker Genzyme about problems with its safety procedures at a manufacturing plant in France.
In a letter dated Sept. 19, the Food and Drug Administration said Genzyme's facility in Lycee had several problems associated with the production of a drug used in kidney transplant patients. FDA posted the letter to its Web site Tuesday
In several instances, Genzyme continued manufacturing the product despite excessive levels of bacteria in early batches of the drug. The drug, called Thymoglobulin, is a combination of human and rabbit proteins that stops a patient's body from rejecting an implanted kidney.
FDA inspectors also found excessive levels of bacteria in the water system used in the manufacturing process on at least two occasions.
The inspectors also cited the company for not thoroughly investigating two animals that died in testing of the drug. FDA inspected the plant between June 6 and June 19, 2007.
Genzyme responded to the agency's citations in a July 30 letter, but FDA said a more thorough response is needed.
Company spokesman Dan Quinn said Genzyme will continue manufacturing Thymoglobulin as it addresses the warning letter.
"We're continuing to work with FDA to make sure nothing compromises our ability to produce a high quality product," Quinn said.
Thymoglobulin has been available in the U.S. since 1999. The product had sales of $149.5 million last year.
Shares of Genzyme Corp. rose 83 cents Tuesday to $65.05 in morning trading.
http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D8S16AEO0#adSkip