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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warning Letters

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Recently Posted | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |

Tobacco Retailer Warning Letters

 

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Types of Warning Letters on the FDA Website

Read more about types of warning letters

Topics on this Page: 


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Ways to View/Browse Warning Letters

To view Warning Letters by date:

Or:

  • 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.

To find specific Warning Letters:

  • Perform a simple search by entering criteria into the search box below.

 

 

 

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 28, 2014 Petaware Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
August 28, 2014 I'm a Little Teacup Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 28, 2014 Blanc du Blanc, Inc. Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 18, 2014 HUMAN SCIENCE FOUNDATION Los Angeles District Office Unapproved Drugs/Misbranded Not Issued *
August 18, 2014 Simply Clean Air & Water Inc. New England District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 15, 2014 Zions Rx Formulations Services LLC dba Rx Formuations Serv. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 14, 2014 Big Easy Confections, L.L.C. New Orleans District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
August 13, 2014 www.nefsak.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 12, 2014 Ad-Med Biotechnology, LLC Detroit District Office Unapproved New Drugs/Misbranded Not Issued *
August 12, 2014 The Compounding Shop, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 12, 2014 Masimo Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 Childrens Medical Ventures Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 08, 2014 EnerHealth Botanicals, LLC Denver District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 07, 2014 Explora Laboratories Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
August 07, 2014 Colgate Oral Pharmaceuticals, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) August 21, 2014
August 07, 2014 Korea United Pharm Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
August 01, 2014 Geetanjali Inc., d/b/a Tobacco World Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 01, 2014 Peter Bacle dba Stock Island Lobster Company Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 25, 2014 William Rausch Cincinnati District Office Illegal Drug Residue Not Issued *
July 18, 2014 Calaire Chimie S.A.S. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *



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Contact FDA

301-827-6860
Fax:301-827-6870
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Rockville, MD 20852
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