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Hemarus LLC, a biologics manufacturer of blood and blood products, was cited for significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Parts 606 and 640 that rendered their products adulterated. The FDA's April 2024 inspection documented failures including the responsible physician's failure to approve donor reinstatement into the plasmapheresis program after protein composition values returned to acceptable levels, with a specific example showing source plasma was collected from a donor on April 26, 2024, without proper physician approval despite normalized test results from April 2, 2024. The warning letter indicates additional personnel and procedural failures related to collection, processing, compatibility testing, storage, and distribution of blood and blood components were also documented.