FDA 483 - BOEHRINGER INGELHEIM PROMECO S.A. de C.V. - December 06, 2019

An FDA inspection of Boehringer Ingelheim Promeco S.A de C.V. in Xochimilco, Mexico City, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate discrepancies, submit timely Field Alert Reports for out-of-specification results, and conduct stability studies in a timely manner. These issues indicate a lack of robust quality oversight and compliance with regulatory requirements.