483
ROi CPS LLCROi CPS LLC – FDA 483, Oct 28, 2022
Record Details
ROI CPS LLC, a manufacturer of Class II surgical kits in Republic, MO, was cited for significant deficiencies in its quality system. The inspection revealed inadequate corrective and preventive action procedures, leading to repeat nonconformities, and a failure to adequately establish procedures for ensuring purchased products and services meet specified requirements, particularly concerning supplier qualification. These issues indicate a systemic breakdown in quality management.
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