FDA 483 - Hetero USA Inc - March 17, 2017

Hetero USA Inc. was cited for significant deficiencies in its post-marketing adverse drug experience reporting. The firm failed to submit numerous periodic adverse drug experience reports (PADERs) on time, with many reports entirely missing and others submitted late. Additionally, Hetero USA Inc. lacked written procedures for handling PADERs and customer complaints, and failed to submit required reports in the mandated electronic format.