FDA 483 - BioMed ENT, Inc - June 24, 2025

BioMed ENT, Inc. in Milwaukee, WI, was inspected regarding its HCT/P-Ambient Warehouse operations. The inspection revealed significant deficiencies in record-keeping for human tissue product storage temperatures and equipment calibration. Additionally, the firm failed to establish, maintain, and follow appropriate procedures for manufacturing and distribution activities, indicating a lack of adherence to core CGTP requirements.