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New York Fertility Institute's - Authorization to Resume Limited HCT/P Manufacturing Operations

April 30, 2014

 
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Dear ---(b)(4)----:
 
We received New York Fertility Institute’s (NYFI) letter dated April 25, 2014, which responded to FDA’s letter dated April 23, 2014, authorizing NYFI to resume limited HCT/P manufacturing operations under the Order to Cease Manufacturing of HCT/Ps (Order) issued to NYFI on March 1, 2013. Based on FDA’s review of the documentation submitted by NYFI and the information collected during an on-site inspection, FDA originally provided written authorization for NYFI to perform the following HCT/P manufacturing operations: 
 
  • Donor screening;
  • Donor testing;
  • Donor eligibility determinations.
 
In response to NYFI’s April 25, 2014 request for authorization to perform additional manufacturing operations, FDA hereby provides authorization for NYFI to perform HCT/P recovery in addition to the donor screening, donor testing, and donor eligibility determinations that were previously authorized. NYFI is not authorized to utilize HCT/Ps from anonymous or directed donors at this time. 
 
Until such time as FDA completes a subsequent on-site inspection to determine NYFI’s compliance with 21 CFR 1271 in performing the above listed manufacturing operations, and a written determination regarding NYFI’s compliance is communicated to NYFI, NYFI remains subject to FDA’s March 1, 2013 Order. Additionally, NYFI must continue to store in quarantine HCT/Ps that are subject to the Order, in accordance with 21 CFR 1271.60, and must not remove them from storage or utilize them without prior written authorization from FDA. 
 
                                                                        Sincerely,
 
 
                                                                        Mary A. Malarkey
                                                                        Director
                                                                        Office of Compliance and Biologics Quality
                                                                        Center for Biologics Evaluation and Research
 
 
cc:        Majid Fateh, M.D.
             Medical Director
             New York Fertility Institute
            1016 5th Avenue
             New York, NY 10028