ORCHID UNIQUE – FDA 483, Sep 5, 2019

Unique Instruments, Inc. in Bridgeport, MI, a medical device establishment, received a Form FDA-483 with six observations during an inspection from August 22 to September 5, 2019. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for nonconforming product control, process parameter monitoring, corrective and preventive actions, complaint investigations, statistical techniques, and management review. Several of these observations were repeats from a previous inspection, indicating persistent issues.