FDA 483 - Bioteque America, Inc - April 23, 2025

Bioteque America, Inc. in Richardson, TX, a manufacturer of Class I/II gynecological medical devices, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate procedures for MDRs, supplier management, corrective and preventive actions, risk analysis, equipment maintenance, and a complete lack of UDI listings in the GUDID for its products. These issues indicate a broad failure to maintain a compliant quality system.