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CLOSEOUT LETTER

Meditech Laboratories, Inc


Recipient:
Meditech Laboratories, Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road, Irvine, CA 92612-2506 

 
 

December 6, 2017

Michael B. Bitar, PharmD, Pharmacist-in-Charge
Meditech Laboratories, Inc.
3200 Polaris Ave Suite #27
Las Vegas, NV 89102

Dear Dr. Bitar:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Reference No. CMS 506537) dated October 19, 2016. We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/

Mark C. Saale
Acting Director, Compliance Branch
Division of Pharmaceutical Quality Operations IV