ARx LLC – FDA 483, Jun 10, 2026

An FDA inspection of ARX LLC, a contract human drug manufacturer in Glen Rock, PA, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to thoroughly investigate confirmed microbial contamination in its USP water system, leading to the distribution of potentially impacted drug products without adequate testing. Additionally, the inspection cited failures in finished drug product release testing, deficient laboratory investigations, inadequate equipment cleaning, and poor record-keeping practices, including a repeated observation.