FDA 483 - IVF Laboratories of Grand Rapids LLC - April 27, 2023

An FDA inspection of IVF Laboratories of Grand Rapids LLC, a reproductive HCT/P establishment in Grand Rapids, MI, identified one observation. The firm failed to clearly identify human cells, tissues, and cellular and tissue-based products (HCT/Ps) as quarantined while awaiting the completion of donor eligibility determinations. This indicates a deficiency in their quarantine procedures for donor materials.