Gentuity, LLC – FDA 483, Mar 5, 2026

Gentuity, LLC in Sudbury, MA, received a Form FDA 483 with seven observations detailing significant quality system deficiencies. The inspection revealed failures in reporting field actions, inadequate corrective and preventive actions, and insufficient design control validation for software and device components. Additionally, the firm demonstrated poor complaint handling, flawed supplier evaluation, inadequate incoming product verification, and systematic underestimation of risks in their risk management activities, indicating a severe lack of control over critical medical device processes.