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  5. Techni Med, Inc. dba The Compounder - 493750 - 05/05/2020
  1. Warning Letters

CLOSEOUT LETTER

Techni Med, Inc. dba The Compounder MARCS-CMS 493750 —

Delivery Method:
UPS Next Day
Reference #:
CHI-10-16
Product:
Drugs
Recipient:
Recipient Name
Lawrence J. Frieders
Recipient Title
Owner and Pharmacist in Charge
Techni Med, Inc. dba The Compounder

340 Marshall Avenue
Unit 100
Aurora, IL 60506-5649
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

(313) 393-8100

Dear Mr. Frieders:

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 #CHI-10-16) dated July 29, 2016. 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 ensure 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

 
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