FDA 483 - Norbrook Laboratories Limited - July 26, 2019

Norbrook Laboratories Limited, a sponsor and GLP facility in Newry, United Kingdom, was cited for significant deficiencies in its pharmacovigilance system during an FDA inspection. The firm failed to ensure comprehensive adverse drug event reporting from distributors and a contracted call center, did not properly incorporate literature-found adverse events into periodic reports, and frequently submitted these reports late. These issues indicate a systemic failure to maintain adequate records and timely reporting for new animal drugs.