FDA 483 - Shore Institute For Reproductive Medicine, P.C. - March 05, 2008

The FDA inspected Shore Institute for Reproductive Medicine, P.C. in Lakewood, NJ, an in vitro fertilization establishment. The inspection revealed significant deficiencies in donor screening and testing for communicable diseases, as well as inadequate documentation for donor eligibility determinations and procedure approvals. These issues indicate a serious lack of control over the safety and eligibility of oocyte donors and the HCT/Ps derived from them.