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Warning Letters
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To view Warning Letters by date, use the left-hand navigation column to select a year in which a Warning Letter was issued. You may further refine your search by using our "Browse By..." functions below. To search for Warning Letters and download information about those Warning Letters to an Excel document, you can use the Search and Export Warning Letters to Excel function. To do perform a simple search enter your criteria into the search box below.
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All Warning Letters posted prior to June 25th, 2001 are in PDF format. Warning Letters posted after June 25, 2001 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 recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular Warning Letter on this Web site, please contact the Agency. 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 on our Web site: How to Make a FOIA Request.
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| August 18, 2009 | BioCentric Laboratories Inc. | Denver District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | MEKT LLC | New Jersey District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Meditrend, Inc | Denver District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Wonder Laboratories | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Core Products Int'L Inc | Minneapolis District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Progressive Emu Inc. | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Geromatrix Nutraceutical Corporation | Florida District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 17, 2009 | Allergan Inc. | Division of Drug Marketing, Advertising, and Communications | Labeling/Promotional Claims False & Misleading/Misbranded |
| August 13, 2009 | Ninth St. Management Inc. (Trades as Superior Pasta Co Inc.) | Philadelphia District Office | CGMP for Foods/Seafood HACCP/Adulterated |
| August 11, 2009 | Living Streams Mission, Inc | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| August 11, 2009 | Ridge Medical Products LLC | Dallas District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 10, 2009 | Johnson & Johnson Pharmaceutical Research & Development, LLC | Center for Drug Evaluation and Research | Sponsor |
| August 05, 2009 | Mexican Village Wholesale Foods, Inc | Minneapolis District Office | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded |
| July 17, 2009 | La Madeleine Gourmet Foods, Inc. | Dallas District Office | Seafood HACCP/Adulterated |
| June 23, 2009 | Island Supplements | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| June 09, 2009 | Universal Blanchers LLC | Dallas District Office | CGMP/Adulterated |
| June 08, 2009 | DS Waters of America, LP | Center for Food Safety and Applied Nutrition | Food Labeling/Adulterated/Misbranded |
| June 08, 2009 | Health Food Emporium | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| May 15, 2009 | Healing Edge Science | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| May 05, 2009 | Muvezi Inc. | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| March 30, 2009 | Dragon Waves Frozen Food Factory Co., Ltd. | Center for Food Safety and Applied Nutrition | Seafood HACCP |