FDA 483 - Hi-Dow International Inc - September 15, 2022

Hi-Dow International Inc., a specification developer and complaint file establishment for Class II Transcutaneous Nerve Stimulators (TENS) in Maryland Heights, MO, received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, lack of design controls, and insufficient corrective and preventive actions. Many of these issues were repeat observations from previous inspections, indicating a persistent failure to establish and maintain a compliant quality system.