CSL Ltd. (CSL), the world’s second- biggest maker of blood-derived therapies, says many of the concerns raised in audits conducted by the U.S. Food and Drug Administration in 2010 and 2011 have been addressed.
“These aren’t new issues,” spokeswoman Sharon McHale said today after the Australian newspaper published a story saying the FDA raised concerns about CSL’s manufacturing practices. “These are routine inspections the FDA does, and aren’t a final determination of compliance.”
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