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  5. Family Fertility Center - 588805 - 05/11/2020
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CLOSEOUT LETTER

Family Fertility Center MARCS-CMS 588805 —

Reference #:
OBPO 19-11
Product:
Biologics
Recipient:
Recipient Name
Michele R. Birsinger
Recipient Title
Assistant Vice President
Family Fertility Center

6651 Main St.
Ste. E350
Houston, TX 77030-2352
United States

Issuing Office:
Office of Biological Products/Division II Compliance Branch

United States

Dear Ms. Birsinger:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter #OBPO 19-11 issued September 30, 2019. Based on our evaluation, it appears that you have addressed the violation(s) 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 Federal Food, Drug, and Cosmetic Act and its implementing regulations 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.

If you have any questions, please do not hesitate to contact me by phone at (616) 233-9311 extension 1017 or by email at Michele.Forster@fda.hhs.gov.

Sincerely,
/S/
Michele L. Forster, PhD
Compliance Officer

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