FDA 483 - RMG ART Laboratories, LLC - July 12, 2019

RMA ART Laboratories, Inc. in Temple Terrace, FL, was cited for significant deficiencies in the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed that reproductive tissues from ineligible donors and those from sexually intimate partners, for which donor eligibility was not determined, lacked required biohazard legends and warnings regarding communicable disease risks. These issues indicate a failure to properly identify and label HCT/Ps with potential health risks to recipients.