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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 18, 2009 Natren, Inc. Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 17, 2009 Niitikaya USA Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
June 16, 2009 International Desserts and Delicacies Los Angeles District Office CGMP Regulation For Food/Adulterated N/A *
June 16, 2009 Matrixx Initiatives, Inc. AKA Zicam LLC Center for Drug Evaluation and Research OTC Drug Labeling/New Drug/Misbranded N/A *
June 16, 2009 Zosa, Noli R., M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
June 15, 2009 Sunshine Peanut Company Florida District Office CGMP/Foods/Insanitary Conditions N/A *
June 15, 2009 Dennis Paper and Food Service New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 15, 2009 Arkray Factory, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
June 12, 2009 Linzer, Dov M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
June 12, 2009 Circle of Health, Inc, www.ayurveda-herbs.com Seattle District Office New Drug/Labeling/Misbranded N/A *
June 11, 2009 Meridian Lifeforce, Inc Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 10, 2009 Inditherm Medical Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
June 10, 2009 Arjo Med. AB Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
June 09, 2009 Universal Blanchers LLC Dallas District Office CGMP/Adulterated N/A *
June 08, 2009 North Valley Veterinary Clinic, Inc. Seattle District Office Illegal Drug Residue N/A *
June 08, 2009 Health Food Emporium Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 08, 2009 DS Waters of America, LP Center for Food Safety and Applied Nutrition Misbranded/Labeling/Unauthoriz ed Health Claims N/A *
June 05, 2009 Nature's Sunshine Products Inc Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 05, 2009 Frantz Design, Inc Dallas District Office CGMP/QSR/Medical Device Reporting/Misbranded N/A *
June 05, 2009 The South Bend Chocolate Company, Inc. Detroit District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *



 

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