Home » Amphastar Slow to Report SAEs, Form 483 States
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
Drug GMP Report
Upcoming Events
-
28Mar
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May