FDA 483 - Clinical Resolution Laboratory Inc. - April 27, 2021

An FDA inspection of Clinical Resolution Laboratory Inc. in Brea, CA, revealed severe and systemic deficiencies in their manufacturing of OTC drug products. The firm lacks an adequate Quality Control Unit, has untrained personnel, and fails to maintain proper complaint procedures, production controls, batch records, and equipment maintenance. These issues, including repeat observations, indicate a fundamental lack of adherence to Current Good Manufacturing Practices.