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  5. Calvin Scott & Company, Inc. - 606987 - 08/04/2023
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CLOSEOUT LETTER

Calvin Scott & Company, Inc. MARCS-CMS 606987 —

Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs

Recipient:
Recipient Name
Jan-Erik Palm
Recipient Title
President
Calvin Scott & Company, Inc.

209 Eubank Blvd NE
Albuquerque, NM 87123
United States

jepalm@calvinscottinc.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States


Dear Mr. Palm: 

The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #606987) dated August 25, 2020. 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 the 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/
CDR Steven E. Porter, Jr. 
Director, Division of Pharmaceutical Quality Operations IV

 
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