FDA 483 - Pharmalogic Los Angeles, LLC - February 05, 2026

An FDA inspection of PharmaLogic Los Angeles, LLC, a manufacturer of PET drugs, revealed a significant deficiency in their quality system. The firm failed to approve or reject processes and procedures before implementation, specifically regarding the visual inspection of PET drug products. This issue raises concerns about the adequacy of operator training and the ability to detect defects, potentially impacting drug identity, strength, quality, and purity.