FDA 483 - Innovative Medical Technologies Inc - September 28, 2023

Innovative Medical Technologies Inc in Omaha, NE, was inspected regarding its specification development. The inspection revealed significant deficiencies in the firm's design control operations, specifically regarding the establishment of design history files, including design inputs and outputs, and the adequate establishment of design validation procedures for its UltraFlo-L, Blood Collection Set. These issues indicate a lack of proper documentation and approval processes for medical device design.