FDA 483 - Breas Medical, Inc. - February 06, 2020

Breas Medical, Inc. in North Billerica, MA was inspected from February 4-6, 2020, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's complaint handling procedures, leading to significant delays in complaint closure. Additionally, the firm failed to adequately maintain device history records, specifically lacking primary identification labels and other required device identifiers for production units.