FDA 483 - Nordson Medical Design and Development, Inc. - October 31, 2023

Nordson Medical Design and Development, Inc. in San Jose, CA, a contract device manufacturer, received two observations during an FDA inspection. The firm was cited for failing to validate a cleaning process for a medical device and for not having adequately established procedures to prevent contamination during material transfer into a controlled environment room. These findings indicate deficiencies in process validation and contamination control practices.