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.
Drug GMP Report