FDA 483 - Boehringer Ingelheim Animal Health Puerto Rico LLC - March 29, 2019

An FDA inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC in Barceloneta, PR, revealed a significant failure to thoroughly review unexplained discrepancies. The firm did not adequately investigate out-of-specification environmental monitoring events or take sufficient action to mitigate recurring issues in a high-risk manufacturing area. This indicates deficiencies in their quality operations and investigation processes.