FDA 483 - KSL Biomedical, Inc. - October 24, 2025

An FDA inspection of KSL Biomedical, Inc., a medical device manufacturer in Buffalo, NY, revealed significant deficiencies in their quality system. Observations included inadequate procedures for design output, lack of documentation for incoming product acceptance or rejection, and failure to provide required information to the Global Unique Device Identification Database (UDID). These issues indicate a need for improved quality system controls and documentation practices.