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Home » Documentation, Procedural Shortfalls Spur Form 483 for Fresenius
Documentation, Procedural Shortfalls Spur Form 483 for Fresenius
August 6, 2012
Dialysis-drug maker Fresenius has been handed a Form 483 after an FDA inspection of its Ogden, Utah, facility raised concerns that post-sterilization visual inspections performed on solution bags may not be effective at catching leaks or contaminants.