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  5. Village Fertility Pharmacy, Inc. - Close Out Letter 7/25/16
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CLOSEOUT LETTER

Village Fertility Pharmacy, Inc.


Village Fertility Pharmacy, Inc.

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.75561

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

July 25, 2016

Mr. Stuart P. Levine
Village Fertility Pharmacy, Inc.
335 Bear Hill Road
Waltham, MA 02451

Dear Mr. Levine:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL # 398-380) dated February 28, 2014. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. Therefore, we consider the inspection to be closed.

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/

Joseph Matrisciano, Jr.
District Director
New England District