FDA 483 - BioMed Diagnostocs, Inc - May 06, 2022

BioMed Holdings LLC, a manufacturer in White City, OR, was cited for nine observations during an FDA inspection from May 2-6, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, complaint handling, equipment calibration and maintenance, environmental control, nonconforming product, supplier management, training, and internal audits. These issues indicate a systemic lack of adherence to established quality management principles.