FDA 483 - The Sperm and Embryo Bank of New Jersey, Inc. - September 05, 2023

The FDA issued a Form 483 to The Sperm and Embryo Bank of New Jersey, Inc. in Mountainside, NJ, following an inspection of their human reproductive tissue establishment. The inspection revealed significant deficiencies related to donor screening and testing practices. Specifically, the firm failed to perform timely communicable disease testing, omitted required testing for certain cell-associated diseases, and did not properly determine and document donor eligibility.