FDA 483 - Escalon Medical Corp. - November 25, 2019

Escalon Medical Corp. in New Berlin, WI, a medical device manufacturer, was cited for numerous quality system deficiencies during an FDA inspection. The observations highlight inadequate procedures for finished device acceptance, process validation, environmental controls, and personnel practices. Several issues, including environmental controls, complaint handling, personnel training, CAPA, and internal audits, were repeat observations from a 2013 inspection.