FDA 483 - Boston Scientific de Costa Rica SRL - June 02, 2022

An FDA inspection of Boston Scientific De Costa Rica, S.R.L. in El Coyol, Alajuela, Costa Rica, identified deficiencies in production and process control. The firm was cited for using numerous uncalibrated air pressure gauges in manufacturing and for not having specified regulator settings for these critical pieces of equipment. These conditions indicate a lack of adequate control over manufacturing processes for their medical devices.