FDA EIR - M FATEH & K SULTAN M D S P C - September 05, 2012

An FDA inspection of New York Fertility Institute, a reproductive tissue establishment, was conducted from August 23 to September 5, 2012. The inspection, performed under Compliance Program C.P.7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and regulated by 21 CFR Part 1271 and Section 361 of the PHS Act, identified multiple significant violations. Key issues included the failure to perform NAT HIV-1 and NAT HCV testing on anonymous oocyte donors, insufficient screening for Chlamydia trachomatis and Neisseria gonorrhea, and the use of tissues from a donor who tested positive for Hepatitis B core Antibody. Additionally, donor specimens for communicable disease testing were not collected within the appropriate timeframe (7 days before or after recovery). The firm also lacked established and consistently followed procedures for donor eligibility determination, and maintained inaccurate or inaccessible eligibility records. The company's management agreed to address these observations and committed to a written response within 15 business days. The FDA concluded with an "Official Action Indicated" (OAI) decision, suggesting potential further regulatory action, including a Warning Letter, and advised the firm to file a Biological Product Deviation Report.