Vention Medical – FDA Warning Letter, Mar 6, 2014

The FDA issued a Warning Letter to Vention Medical following an inspection in Barreal de Heredia, Costa Rica, from March 3-6, 2014. The inspection found that the firm's manufactured devices, including thermotherapy and cord blood processing systems, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: failure to adequately validate processes (21 CFR 820.75(a)), specifically for controlled environment cleanliness; failure to establish and maintain procedures for controlling environmental conditions and inspecting systems (21 CFR 820.70(c)), with issues like deficient procedures, a cleanroom gap, and undocumented particulate counts; failure to establish and maintain equipment maintenance schedules, including for the HVAC system (21 CFR 820.70(g)(1)); failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)); and failure to document all CAPA activities and results (21 CFR 820.100(b)).

The firm's undated response was largely deemed inadequate, often lacking evidence of completed corrective actions, personnel training, or systemic reviews. Vention Medical must provide a written response within fifteen business days detailing specific, systemic corrective actions, prevention plans, and a timetable for completion. Failure to correct these violations could impact federal contracts, device approvals, and Certificates for Foreign Governments.