FDAnews Drug Daily Bulletin
Oct. 8, 2012 | Vol. 9 No. 197
Amphastar Slow to Report SAEs, Form 483 States
Amphastar Pharmaceuticals is slow to notify the FDA about complaints of serious and/or unexpected adverse events associated with its various generic drug products, a Form 483 states. During a month-long inspection of the company’s Rancho Cucamonga, Calif., facility in June, agency investigators uncovered a number of complaints that should have been reported to the FDA within 15 calendar days of initial receipt due to their serious nature.
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