FDA 483 - Lonza Bend Inc. - August 05, 2022

An FDA inspection of Bend Research, Inc. in Bend, OR, a contract manufacturer, revealed significant deficiencies in their quality system regarding investigations of unexplained discrepancies. The firm failed to extend investigations to all affected batches and frequently closed investigations without definitive root causes or corrective actions. These issues could result in the distribution of non-conforming drug products.