FDA 483 - Creative Essences Inc. - March 26, 2025

Creative Essences Inc. in Santa Fe Springs, CA, a drug manufacturer, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in equipment calibration and control, including overdue FTIR calibrations and uncalibrated stability chamber monitoring devices. Additionally, the R&D storage room used for holding OTC drug product stability samples was found to be unqualified.