FDA 483 - Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation - May 16, 2023

Jeffrey M. Steinberg MD, Inc. dba The Fertility Institutes, a reproductive fertility center in Encino, CA, was cited for six observations related to donor screening, HCT/P labeling, and donor eligibility determinations. The inspection revealed significant deficiencies in screening for communicable diseases, inadequate labeling of HCT/Ps from both eligible and ineligible donors, and failures to properly document donor eligibility. These issues indicate a moderate level of non-compliance with regulations concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).