Westec Plastic Corporation – FDA 483, Aug 24, 2026

Westec Plastic Corporation, a contract manufacturer in Livermore, CA, was cited for two significant issues during an FDA inspection. The firm failed to adequately plan and develop processes for product realization, specifically lacking a process risk assessment (pFMEA) and documented methodology for its lifecycle. Additionally, the company did not establish risk-based criteria for evaluating and selecting suppliers, nor did it define clear procedures for monitoring and re-evaluating supplier performance proportionate to risk.