FDA 483 - BTE Technologies, LLC - January 31, 2020

BTE Technologies, LLC, a medical device manufacturer in Hanover, MD, was inspected by the FDA, revealing two significant observations. The firm lacked adequately established procedures for design review, including proper planning, independent reviewers, and documentation. Additionally, procedures for controlling nonconforming products were found to be inadequate, specifically regarding justification for disposition and documented rework procedures.