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CLOSEOUT LETTER

Prescription Lab Compounding Pharmacy Jun 27, 2017

Prescription Lab Compounding Pharmacy - Close Out Letter 6/27/17


Prescription Lab Compounding Pharmacy

 

  

Black HHS-Blue FDA Logo

 

 

 
Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Los Angeles, CA 92612

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

June 27, 2017

David A. Nicoletti, R.Ph., President
MFP Limited, dba Prescription Lab Compounding Pharmacy
6586 E. Grant Road
Tucson, AZ 85715

Dear Mr. Nicoletti:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL#07-17) dated November 16, 2016. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s 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/

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV