FDA 483 - Bard Shannon Limited - August 18, 2023

An FDA inspection of Bard Shannon Limited, a medical device manufacturer in Humacao, PR, was conducted from August 14-18, 2023. The inspection resulted in a Form FDA 483, citing multiple observations indicating non-compliance with quality system requirements for medical device manufacturing, pursuant to the Federal Food, Drug and Cosmetic Act. Key issues included inadequate control of environmental conditions, particularly a failure to consistently follow established cleaning procedures for manufacturing areas and flow hoods. This observation was noted as a recurrence from a previous 2018 inspection, impacting products such as Tubular Polyester Mesh. Additionally, the firm did not adequately ensure that purchased products and services conformed to specified requirements; a critical supplier had not been evaluated since 2011, contrary to company procedures. Lastly, deficiencies were found in employee training, with the company unable to provide documentation demonstrating that employees were trained on essential operational and final packaging inspection procedures. Bard Shannon Limited is required to implement comprehensive corrective actions to address these significant deviations and submit a formal response to the FDA.