FDA 483 - Rowny Systems, Inc. - June 17, 2022

An FDA inspection of Rowny Systems, Inc., a software manufacturer in Cabin John, MD, revealed significant deficiencies in its quality system. The firm failed to maintain device history records for its Antigen Plus product and lacked established procedures for device history records, design control, and quality audits. These findings indicate a fundamental lack of adherence to regulatory requirements for medical device manufacturing.