FDA 483 - SGF Tampa Bay LLC - February 24, 2020

SGF Tampa Bay LLC, a reproductive tissue establishment, was cited for multiple deficiencies related to donor screening, record-keeping, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed failures in screening donors for communicable disease risks, incomplete records for ineligible donors, and improper labeling of HCT/Ps with biohazard warnings. Additionally, the firm failed to ensure its contract laboratory complied with good tissue practice requirements and maintained legible donor eligibility records.