FDA 483 - Westwood Laboratories, LLC. - August 02, 2019

Westwood Laboratories, Inc. in Azusa, CA, a contract manufacturer, was inspected by the FDA from July 29 to August 2, 2019. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, non-conforming product control, and environmental condition monitoring. Additionally, issues were noted with device history records not matching device master records and the use of uncontrolled spreadsheets for microbiology data.