FDA 483 - Apex Display Group, LLC - October 31, 2025

An FDA inspection of Apex Display Group, LLC, an OTC packer in Lansdale, PA, revealed significant deficiencies across its quality system. The firm lacked a functional quality control unit, failed to establish adequate laboratory controls for incoming materials, and maintained incomplete batch production and control records. These critical issues indicate a severe lack of adherence to cGMP conditions, raising concerns about the safety, effectiveness, and quality of the drug products packaged.