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CLOSEOUT LETTER

New Hope Fertility Center 12/07/2016

New Hope Fertility Center - Close Out Letter 7/12/16


New Hope Fertility Center

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

July 12, 2016


Dr. John Zhang, Medical Director & Tissue Bank Director
New Hope fertility Center
4 Columbus Circle, Floors 3 & 4
New York, NY 10019-1100

Dear Dr. Zhang:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter NYK-2015-09 issued to you on November 20, 2014. Based on our evaluation of your written responses and follow-up inspection, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21
CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 USC 264) or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

CDR Frank Verni, USPHS
Compliance Officer
FDA - New York District