FDA 483 - West Pharmaceutical Services AZ, Inc - August 19, 2022

Tech Group Scottsdale dba West, a manufacturer in Scottsdale, AZ, was cited for a significant data integrity issue during an FDA inspection. The firm failed to implement appropriate controls over computer systems and electronic records, specifically for flow rate determination data used in releasing SmartDose 10mL Device batches. This lack of control allowed unauthorized personnel to create, copy, modify, and delete original raw data and testing parameters.