FDA 483 - Optikem International, Inc. - July 11, 2022

Optikem International, Inc., a medical device manufacturer in Denver, CO, received two observations during an FDA inspection from July 6-11, 2022. The firm failed to adequately establish and follow procedures for routine equipment calibration, particularly for time-temperature control devices. Additionally, the company has not implemented Unique Device Identifier (UDI) requirements for its medical device products, despite prior FDA guidance.