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

During an FDA inspection from October 27-31, 2025, Apex Display Group, LLC received a Form FDA 483 citing significant deficiencies in their drug product packaging operations. The primary violation identified was the complete absence of a functional quality control unit. This systemic failure led to widespread non-compliance with Current Good Manufacturing Practices (CGMP) under the Federal Food, Drug, and Cosmetic Act. Key issues included a lack of established procedures and documentation for critical quality processes such as component and finished product release, deviation management, change control, equipment validation, and employee training. The company also failed to adequately investigate 12 product quality complaints related to packaging defects. Furthermore, the inspection revealed inadequate laboratory controls, with no scientifically sound specifications or testing for incoming bulk drug products. Batch production records were incomplete, lacking essential information like reconciliation, label control, and quality assurance review for packaged drug products. Apex Display Group, LLC is required to establish and implement a comprehensive quality unit and robust systems, including detailed procedures, thorough documentation, and proper controls for all manufacturing, packaging, and testing activities, to ensure the identity, strength, quality, and purity of their drug products before commercial distribution.