Puerto Rican Facility Called Out for Corrective Actions

May 20, 2019

Inadequate corrective actions at Bard Shannon’s San Juan, Puerto Rico facility netted the company a Form 483 from the FDA.

The agency discovered during its Oct. 22-Nov. 21, 2018 inspection that the firm had failed to  properly implement corrective actions for its OptiFix system for fixation of surgical mesh to tissue during open or laparoscopic surgical procedures, such as hernia repair.

The company received numerous complaints in about detachment of the product’s barrel insert. Design changes were approved and implemented in 2016 but the facility did not take corrective actions for products manufactured before the design changes were implemented, the investigator said.

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