FDA 483 - Sure-Biochem Laboratories, LLC - March 08, 2024

Sure-Biochem Laboratories, LLC in Camden, NJ, was issued a Form 483 following an inspection from March 4-8, 2024, for significant compliance issues. The firm failed to make records associated with drug product control readily available, specifically a three-year raw data retrospective review and a comprehensive independent assessment. These failures occurred despite prior commitments made in response to an FDA Warning Letter, indicating serious concerns regarding data integrity and quality system oversight.