FDA 483 - Lonza Bend Inc. - July 27, 2018

Bend Research Inc. in Bend, OR, was inspected and cited for significant deficiencies in its manufacturing processes. Observations include a lack of written procedures and controls for critical production operations, inadequate qualification of manufacturing equipment and vision systems, and a failure to thoroughly investigate and document manufacturing discrepancies. These issues indicate a systemic weakness in their quality control and assurance systems.