A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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