FDA 483 - S. Jackson, Incorporated - December 10, 2021

This FDA Form 483 was issued to S. Jackson, Incorporated in Alexandria, VA, following an inspection from December 6-10, 2021. The inspection revealed significant deficiencies in the firm's quality management system, including inadequate corrective and preventive actions, incomplete risk analysis, and failures in establishing quality plans and objectives. Several observations were repeat findings, indicating persistent issues with quality system compliance.