FDA 483 - AstraZeneca Pharmaceuticals, LP - January 30, 2018

AstraZeneca Pharmaceuticals, LP in Gaithersburg, MD, was inspected from January 25-30, 2018. The inspection revealed a significant compliance issue where the firm failed to report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. This indicates deficiencies in their pharmacovigilance reporting processes.