S. Jackson, IncorporatedDecember 10, 2021

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

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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.

Company: S. Jackson, Incorporated
Inspection Date: December 10, 2021
Product Type: Device
Office: Office of Regulatory Affairs
Person: Joey C. West (Investigato)

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ID · 21022152-fe64-42ea-8c87-532694abb03b