FDA 483 - BioDlogics LLC - August 08, 2019

BioLogics LLC, an HCT/P manufacturer in Cordova, TN, was cited for significant deficiencies during an FDA inspection. Observations included failure to validate sterilization processes for Amniotic Membrane HCT/Ps, inadequate complaint handling procedures to identify adverse event trends, and failure to report a serious adverse reaction involving a communicable disease to the FDA. These issues indicate a lack of robust quality control and regulatory compliance.