FDA EIR - BioStem Life Sciences - June 13, 2018

An FDA inspection of Anu Life Sciences in Sunrise, FL, was conducted from June 6 to June 13, 2018. This initial inspection focused on the company's processing, packaging, labeling, storage, and distribution of human tissue products, specifically amniotic membrane and fluid. The regulatory framework for this inspection was based on Current Good Tissue Practice (CGTP) regulations, particularly concerning Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps). The primary violation, documented on an FDA-483 form, cited the company's failure to fully validate the processing of their Rheo Amniotic Fluid and Vendaje Amniotic Membrane products. This deficiency meant the company could not assure that its processes consistently prevented contamination, cross-contamination, or the spread of communicable diseases. In addition to this formal observation, seven verbal issues were discussed with management. These included a lack of documented cleaning logs and temperature monitoring in the laboratory, instances of the quality unit approving incomplete documentation, and the absence of a controlled gowning area for the cleanroom. Labeling discrepancies were also noted, such as stating "Zika testing" instead of "screening" and unclear statements regarding confirmed CMV positive tissue results. Furthermore, there was no standard operating procedure for notifying consignees of positive CMV test results. Anu Life Sciences' management acknowledged the observations and committed to submitting a formal written response addressing the FDA-483 finding within 15 business days. Voluntary corrective actions for the verbal observations were also presented by the company.