Inspections, Compliance, Enforcement, and Criminal Investigations
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Warning Letters
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Recently Posted | 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
- 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.
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Or:
- Perform an Advanced Search
- Use any of these "Browse" functions:
To download information about Warning Letters to an Excel document:
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Use the Search and Export Warning Letters to Excel function.
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.
Recently Posted Warning Letters
Posted on September 27, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
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September 21, 2012 | Canadadrugs | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs | Not Issued * |
September 21, 2012 | Sunset Dairy | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
September 19, 2012 | Create-A-Pack Foods, Inc. | Minneapolis District Office | CGMP/Acidified Foods/Adulterated | Not Issued * |
September 19, 2012 | Epimed International, Inc. | New York District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
September 18, 2012 | Fayus, Inc. dba Yusol International Foods | San Francisco District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
September 18, 2012 | Hopkins, E Frank Co., Inc. | Philadelphia District Office | CGMP for Foods/Adulterated | Not Issued * |
September 18, 2012 | Arkadiy Kisin/White Forest Solutions | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs | Not Issued * |
September 18, 2012 | Pronet/Eyal Bar Oz | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs | Not Issued * |
September 18, 2012 | EyeScience Labs, L.L.C. | Cincinnati District Office | Promotional Claims False & Misleading/New Drugs | Not Issued * |
September 14, 2012 | Nunes Brothers Dairy | Seattle District Office | Illegal Drug Residue | Not Issued * |
September 14, 2012 | www.cigarettes-com.net | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
September 13, 2012 | Greens Wholesale Distributors, Inc. | New Orleans District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
September 10, 2012 | Monarch Seafoods, Inc. | San Francisco District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
September 07, 2012 | Chassy Bagels, Inc. dba House of Bagels, Inc. | San Francisco District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | Not Issued * |
September 05, 2012 | Atlanta Dental Supply Company, Inc . | Atlanta District Office | X-Ray Systems | Not Issued * |
August 30, 2012 | Aino Co., Ltd. of North China Pharmaceutical Group | Center for Drug Evaluation and Research | Failure to register and list | Not Issued * |
August 27, 2012 | Indus Enterprises, Inc. d/b/a Texas Jasmine | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
August 23, 2012 | Marks Marine Pharmacy | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs | Not Issued * |
August 16, 2012 | EEG Info | Los Angeles District Office | Device/Adulterated/Misbranded | Not Issued * |
August 01, 2012 | Endogastric Solutions, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Not Issued * |
July 20, 2012 | Arriol International Corp. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
June 05, 2012 | CardioMEMS, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Not Issued * |
May 24, 2012 | DMC Medical Ltd | Center for Devices and Radiological Health | CGMP for Medical Devices/QS/Adulterated | Not Issued * |
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Contact FDA
301-827-6860
Fax:301-827-6870
Dockets Management
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061, HFA-305
Rockville, MD 20852
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