FDA 483 - Hemarus LLC - April 30, 2024

An FDA inspection of Hemarus LLC, a Source Plasma Donor Center in Lauderhill, FL, revealed significant deficiencies across multiple areas of operation. The firm failed to adhere to standard operating procedures, maintain adequate records, ensure proper personnel training, and thoroughly investigate adverse events. Several critical issues, including inadequate donor privacy and adverse reaction investigations, were repeat observations from a previous inspection, indicating persistent compliance problems.