FDA 483 - Vireo Resources, LLC - August 11, 2022

Vireo Resources LLC, a manufacturer in Plattsmouth, NE, was cited for significant deficiencies in its manufacturing and quality control processes for both drug products (pH-D Feminine Health Suppositories) and dietary supplements. Observations included failures in finished product and raw material testing, lack of stability and process validation programs, inadequate control records, and insufficient annual product reviews. These issues indicate a systemic lack of adherence to good manufacturing practices.