FDA 483 - The New York Fertility Center - June 15, 2021

The New York Fertility Center in Flushing, NY, received a Form 483 for significant deficiencies in its reproductive human tissue operations. The inspection revealed failures in determining oocyte donor eligibility based on screening and testing, including issues with documentation and risk factor assessment. Additionally, the firm's standard operating procedures were found to be inadequate, and non-FDA-cleared tests were used for communicable disease screening.