FDA 483 - Sofie Co. - January 22, 2019

Sofie Co. dba Sofie, a PET Manufacturer in Kansas City, MO, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to conduct investigations into numerous environmental monitoring excursions and 33 Out-of-Specification events for manufactured lots. Additionally, the inspection revealed a failure to properly calibrate critical equipment, with pressure gauges remaining uncalibrated for several years.