FDA 483 - Pharmalogic Salt Lake City, LLC - February 24, 2026

Pharmalogic Salt Lake City, LLC, a PET Drug Manufacturer, was cited for failing to take appropriate action to prevent the recurrence of quality problems. The inspection revealed multiple instances of operator error in QC analytical chromatography testing for finished drug products, where awareness training proved inadequate in preventing repeat incidents. This indicates a systemic issue in their quality system's corrective action effectiveness.