Radiopharmaceutical firm Ion Beam Applications (IBA) of Louvain-la-Neuve, Belgium, has responded to a warning letter from the U.S. Food and Drug Administration (FDA) related to manufacturing practices for PET radiotracers at a facility in Virginia.
In a letter dated October 24, the FDA said that an inspection of the company's manufacturing facility in Sterling, VA, in May 2008 "revealed significant deviations" from U.S. Pharmacopoeia compounding standards and official monographs for PET drug manufacturing. The letter stated that the facility manufactured IBA's only PET radiopharmaceutical and that the May visit was the site's first inspection.
The letter found fault with IBA's documentation and validation of its sterilization procedures at the plant, as well as the company's procedures for investigating out-of-specification test results. The FDA also would like to see changes to the company's equipment maintenance and inspection procedures, the letter said. The letter gave IBA 15 working days to respond.
IBA believes that it has addressed the FDA's observations appropriately, according to vice president of marketing Michelle Ernsdorff.
"IBA is confident that our overall process has always included the appropriate checks and balances needed to ensure patient safety," Ernsdorff said. "While the industry awaits the final ruling on the regulation of PET radiopharmaceuticals by the FDA (21 CFR 212), IBA remains committed to the contents of U.S. Pharmacopoeia for PET radiopharmaceutical compounding. We take our regulatory and patient safety responsibilities very seriously and remain committed in these efforts."
Related Reading
IBA opens production center in Dallas, December 2, 2008
IBA signs deal with Biotech Cyclotron, December 1, 2008
IBA's interim Q3 report shows mixed results, November 19, 2008
IBA to develop PET market in South Korea, September 25, 2008
IBA adds MI order, September 24, 2008
Copyright © 2008 AuntMinnie.com
