BOX MEDICAL SOLUTIONS INC. – FDA 483, Jan 30, 2020

An FDA inspection of BOX MEDICAL SOLUTIONS INC. in Thousand Oaks, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for incomplete validation of device software, a lack of established design control procedures, and inadequate procedures for finished device acceptance. These issues indicate a moderate level of non-compliance with regulatory requirements for medical device manufacturing.