Steritec Products Mfg. Co., Inc. – FDA 483, Dec 1, 2022

Steritec Products Mfc. Co., Inc. in Englewood, CO, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design history files for Class II Migrating Indicator Strips, insufficient procedures for acceptance activities, and failures in controlling nonconforming products. These issues suggest a systemic lack of adherence to regulatory requirements for medical device manufacturing.