FDA 483 - Custom Healthcare Systems of VA, LLC - September 04, 2019

Custom Healthcare Systems, Inc. in Richmond, VA, a medical device manufacturer, received a Form FDA-483 citing four significant quality system deficiencies. The observations included a lack of documented justification for not reporting a medical device recall, inadequate supplier qualification for sterilization services (a repeat observation), and failures in incoming product acceptance procedures and internal quality audits. These findings highlight critical areas for improvement in the firm's adherence to regulatory requirements.