FDA WARNING_LETTER - Hemarus LLC - April 30, 2024

On October 8, 2024, the FDA issued a Warning Letter to Hemarus LLC following an inspection from April 15-30, 2024, at their Lauderhill, Florida facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) requirements for blood and blood components (21 CFR Part 606) and biological product standards (21 CFR Parts 610-640), rendering their products adulterated under the FD&C Act.

Key violations include: 1. **Failure to approve donor reinstatement:** A responsible physician did not approve a donor's reinstatement into the plasmapheresis program after protein levels returned to normal, yet plasma was collected. (21 CFR 640.65(b)(2)(i)) 2. **Inadequate personnel training:** Nine physician substitutes lacked required training per SOP 03.05, impacting product safety, purity, and potency. (21 CFR 606.20(b)) 3. **Failure to follow SOPs:** Freshly collected Source Plasma was placed directly into cardboard boxes in a freezer, deviating from SOP 06.15 requiring individual freezing in crates for airflow. (21 CFR 606.100(b)) 4. **Inadequate investigation of discrepancies:** 20 out of 26 Internal Investigation Reports