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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warning Letters


Recently Posted | 2017 | 2016 | 2015 | 2014 | 2013 | 2012

Archived Warning Letters: 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Tobacco Retailer Warning Letters



Types of Warning Letters on the FDA Website

Read more about types of warning letters

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Ways to View/Browse Warning Letters

To view Warning Letters by date:


  • Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.


Letter Issue Date Company Name Issuing Office Subject Close Out Date
06/05/2017 Andropharm, LLC Dallas District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
06/05/2017 Hardcore Formulations Dallas District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
05/26/2017 Star Health & Beauty LLC Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/25/2017 Big Dan's Fitness / Nutrition, LLC Los Angeles District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
05/22/2017 Sewaren Innovative Pharmaceutical Packaging dba SIPP New Jersey District Office Drug Product/Adulterated Not Issued *
04/24/2017 Qinhuangdao Zizhu Pharmaceutical, Co. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
01/17/2017 Avicola Santos, Inc. San Juan District Office Food/Egg/Prepared Packed or Held Under Insanitary Conditions/Adulterated Not Issued *

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ICECI Warning Letters

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