Mannkind Corporation – FDA 483, Oct 3, 2024

An FDA inspection of Mannkind Corporation, a manufacturer of the V-Go wearable insulin delivery device, identified significant deficiencies in their quality system. Observations included inadequate statistical rationale for sampling, insufficient design change verification for water resistance, and a failure to validate the device's conformity to user needs regarding adhesion. Additionally, the firm's corrective and preventive action procedures were not fully implemented or verified, and complaint investigations were found to be inadequate, leading to potential patient safety risks.