Optikem International, Inc. – FDA 483, Mar 1, 2024

Optikem International, Inc. in Denver, CO, a medical device manufacturer, was cited for significant deficiencies across multiple quality system areas during an FDA inspection. The inspection revealed inadequate validation of aseptic processes and equipment, poorly established environmental controls, and a lack of routine equipment calibration. Furthermore, the firm failed to establish adequate procedures for corrective and preventive actions, design validation, risk analysis, and design verification for its Class II medical devices, with some issues being repeat observations from previous inspections.