FDA 483 - Tandem Diabetes Care, Inc. - March 23, 2023

An FDA inspection of Tandem Diabetes Care, Inc. in San Diego, CA, a manufacturer of insulin pumps, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA), with multiple CAPAs lacking sufficient actions to prevent recurrence of issues related to t:slim X2 Insulin Pumps. Additionally, the firm's post-market risk assessment procedures were found to be inadequate, potentially leading to an underestimation of hazard probabilities and insufficient risk mitigation for serious issues like inadequate insulin delivery.