Hemarus LLC

Warning LetterOpen

Padmasree Chigurupati Vice President of Quality and Regulatory Affairs Hemarus LLC 4600 Military Trail, Suite 224 Jupiter , FL 33458-4813 United States padma@hemarus.comFEI 3019769008Issued Oct 8, 2024Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3019769008.

Letter Details

Firm: Hemarus LLC
Location: Padmasree Chigurupati Vice President of Quality and Regulatory Affairs Hemarus LLC 4600 Military Trail, Suite 224 Jupiter , FL 33458-4813 United States padma@hemarus.com
FEI Number: 3019769008
Country: United States
Issue Date: October 08, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

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.