FDA 483 - Tessy Plastics Corporation - February 20, 2026

Tessy Plastics Corp., a medical device contract manufacturer in Elbridge, NY, received two observations during an FDA inspection. The firm was cited for inadequately documenting its risk management processes, including deficiencies in process failure modes and effects analyses. Additionally, nonconforming product was accepted by concession without sufficient justification, approval, or adherence to regulatory requirements.