FDA 483 - Sure-Biochem Laboratories, LLC - October 07, 2022

Sure-Biochem Laboratories, LLC, a contract testing laboratory in Camden, NJ, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, operates with inadequate laboratory controls and unvalidated test methods, and consistently fails to follow its own standard operating procedures. These issues indicate a severe lack of control over testing processes for OTC drug products and environmental monitoring, raising concerns about data integrity and product quality.