FDA EIR - IVF New York - August 08, 2008

An FDA surveillance inspection was conducted at IVF New York, located at 230 Central Park S, New York, NY, on August 8, 2008. This initial inspection, part of the FDA's FY'08 Tissue Bank Workplan, operated under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically C.P 7341.002, and noted the facility's NYSDOH licensing. The inspection focused on IVF New York's operations as a site for reproductive tissue procurement, processing, implantation, and insemination, covering areas such as tissue firm registration, donor eligibility, quality assurance, and tracking systems. The facility handles oocytes, embryos, and semen from client depositors, performing various processes like minimal manipulation and cryopreservation. While the inspection concluded with "No Action Indicated" (NAI) and no FDA-483 (Inspectional Observations Form) was issued, a verbal observation highlighted a key issue: the company's failure to submit the required annual FDA Tissue Registration (Form FDA 3356) for 2007 and 2008. Dr. Satwant K. Dhamoon, the owner, was informed of this oversight, and guidance on electronic FDA Tissue registration was provided to address this required action. No other significant deficiencies were identified.