Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes – FDA Warning Letter, Aug 8, 2008

On November 18, 2008, the FDA issued a Warning Letter to Jeffrey Steinberg, M.D., Medical Director/President of Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes, following an inspection from July 23, 2008, to August 8, 2008. The inspection revealed significant deviations from 21 CFR Part 1271, governing human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test for relevant communicable diseases (21 CFR 1271.85(c))**: Semen donors were not tested for *Chlamydia trachomatis* and *Neisseria gonorrhea* before their reproductive cells were used for fertilization and embryo transfer to surrogates in multiple instances. 2. **Failure to test for CMV (21 CFR 1271.85(b)(2))**: Semen donors were not tested for cytomegalovirus (CMV) in several cases where their semen was used for fertilization and subsequent embryo transfer. 3. **Failure to collect donor specimens within required timeframes (21 CFR 1271.80(b))**: Specimens from anonymous and directed oocyte donors and a directed semen donor were collected outside the mandated 30 days prior to or 7 days before/after recovery.