FDA 483 - ROM Technologies, Inc. - April 04, 2023

ROM Technologies, Inc. in Brookfield, CT, was inspected from March 28 to April 4, 2023, and received one observation. The inspection revealed that the firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements. This deficiency specifically involved a lack of documented evidence for the periodic assessment of critical suppliers, as required by their own internal procedures.