TELEFLEX LLC – FDA 483, Aug 26, 2022

TELEFLEX LLC, a medical device specification developer in Morrisville, NC, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document corrective and preventive actions, including addressing root causes and monitoring effectiveness for various medical devices. Additionally, procedures for design transfer and control of nonconforming products were found to be insufficient, leading to product issues and unreliable reconciliation of recalled devices.