FDA 483 - Breas Medical, Inc. - January 18, 2022

An FDA inspection of Breas Medical, Inc., a manufacturer of ventilator products in North Billerica, MA, identified one observation. The firm was cited for not adequately establishing procedures to control environmental conditions, specifically regarding electrostatic discharge (ESD) or electrical overstress (EOS) for powered tools used in servicing ventilator products. This indicates a deficiency in their quality system for environmental controls.