483
Pharmalogic Salt Lake City, LLCPharmalogic Salt Lake City, LLC – FDA 483, Feb 24, 2026
Record Details
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.
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ID · 26288766-8664-471a-8f87-8ccbc8606913
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