483
In VitroTech Labs, Inc.FDA 483 - In VitroTech Labs, Inc. - March 21, 2018
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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.
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ID · 37ff6a4e-052b-41cb-8f8f-83d3aca3b310