FDA 483 - Inno Health Technology, Inc. - September 07, 2023

An FDA inspection of Inno Health Technology, Inc. in Taichung, Taiwan, from September 5-7, 2023, revealed significant deficiencies across multiple quality system areas. The firm's procedures for medical device reporting, complaint handling, nonconforming product, management review, environmental controls, and calibration were found to be inadequate. These issues indicate a lack of robust quality system implementation and compliance with regulatory requirements.