FDA 483 - Tensentric, LLC - April 14, 2023

Tensentric, LLC, a contract manufacturer in Louisville, CO, was inspected by the FDA from April 11-14, 2023. The inspection revealed significant deficiencies in the company's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and follow procedures for effectiveness checks, documentation, and the handling of ineffective CAPAs.