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CLOSEOUT LETTER

Louisville Reproductive Center


Recipient:
Louisville Reproductive Center


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Biological Products Operations
Division II Compliance Branch 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

March 05, 2018

Robert J. Homm, MD
Medical Director
Louisville Reproductive Center
Louisville, KY 40207-4733

Dear Dr. Homm,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 17-03 issued August 29, 2017. Based on our evaluation, 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 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.

Sincerely,
/S/

Dan Cline Captain, USPHS (Ret)
Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations
Division II, Compliance Branch
Tel: 949-608-4433
Daniel.Cline@fda.hhs.gov