Warning Letters

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Tobacco Retailer Warning Letters

 

Types of Warning Letters on the FDA Website

• General FDA Warning Letters
• Tobacco Retailer Warning Letters
• Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)

Read more about types of warning letters

Topics on this Page: 

• Ways to View/Browse Warning Letters
• More Information About Warning Letters Posted Here
• Recently Posted Warning Letters

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Ways to View/Browse Warning Letters

To view Warning Letters by date:

• Review the list of recently posted warning letters below.

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.

 

 

• Or:

  • Perform an Advanced Search
  • Use any of these "Browse" functions:
    • Browse Warning Letters by Company
    • Browse Warning Letters by Issuing Office
    • Browse Warning Letters by Subject
    • Browse Warning Letters with Response Letters
    • Browse Warning Letters with Closeout Letters

  To download information about Warning Letters to an Excel document:

  • Use the Search and Export Warning Letters to Excel function.

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  More Information about Warning Letters Posted Here

  • Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
  • Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
  • Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
  • To obtain available additional information on the current status of an issue in a particular warning letter on this site, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

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  Recently Posted Warning Letters

 

 

Posted on May 14, 2013

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 08, 2013	Entrenet Nutritionals, Inc.	Philadelphia District Office	Unapproved and Misbranded New Drugs	Not Issued *
May 06, 2013	Rubimed AG	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
May 03, 2013	SmartPractice	Center for Biologics Evaluation and Research	False & Misleading Claims/Misbranded	Not Issued *
May 02, 2013	WEBER MEDICAL GMBH	Center for Devices and Radiological Health	Quality System Regulation for Medical Devices/Adulterated	Not Issued *
May 01, 2013	Dale Schmitmeyer Farm	Cincinnati District Office	Illegal Drug Residue	Not Issued *
April 30, 2013	Electromedical Products International, Inc	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
April 30, 2013	support@cigarettes-shop.net	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
April 30, 2013	http://www.cigarettes-info.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded	Not Issued *
April 25, 2013	Shippert Medical Technologies	Denver District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
April 16, 2013	Emrich Farms	Philadelphia District Office	Illegal Drug Residue	Not Issued *
April 02, 2013	Juve International, LLC	Denver District Office	New Drug/Labeling/False & Misleading Claims	Not Issued *
March 01, 2013	Desert Rose Manufacturing	Denver District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
February 28, 2013	Interlab S.r.l.	Center for Devices and Radiological Health	Medical Devices/Adulterated	Not Issued *
February 20, 2013	Carrizozo Orchard	Denver District Office	Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *

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