FDA 483 - In VitroTech Labs, Inc. - March 21, 2018

An FDA inspection of In VitroTech Labs, Inc. in West Hollywood, CA, revealed a significant compliance issue related to the distribution of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to ensure that distributed HCT/Ps were accompanied by the required donor-eligibility determination and a complete summary of records for oocyte donors. This indicates a lapse in critical documentation practices for human reproductive tissue.