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