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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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
May 09, 2011 Omar Seafood, Corp Florida District Office Seafood HACCP/Adulterated Not Issued *
May 09, 2011 Zuccaros Fruit and Produce Company, Inc. Minneapolis District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 14, 2012
May 06, 2011 Ten Ren Tea Company of San Francisco, Ltd San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded Not Issued *
May 06, 2011 ADAO, Inc. Denver District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
May 06, 2011 Ten Tea San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded Not Issued *
May 06, 2011 Inez Mattison New York District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
May 06, 2011 Green Hope LLC dba Rosewood Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 05, 2011 Alpha Laboratories, Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated August 06, 2012
May 05, 2011 Evanger's Dog & Cat Food Company, Inc. Chicago District Office Low Acid Canned Foods/Adulterated/Misbranded February 28, 2013
May 05, 2011 Christus Spohn Hospital Corpus Christi - Memorial Campus Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
May 05, 2011 LifeCell Corporation Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
May 05, 2011 Tiny Greens Chicago District Office Unsanitary Conditions/Adulterated Not Issued *
May 04, 2011 Southeast Asian Food Product San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 04, 2011 Venus Pharmaceuticals International, Inc. New York District Office Current Good Manufacturing Practice for Dietary Supplements Not Issued *
May 04, 2011 God's Garden Pharmacy Los Angeles District Office CGMP/Dietary Supplement Not Issued *
May 02, 2011 Le Natural, Inc. San Juan District Office Labeling Drug Claims Not Issued *
May 02, 2011 Valley Wholesale Produce and Seafood Baltimore District Office Seafood HACCP/Adulterated Not Issued *
May 02, 2011 Dani Jacq, Inc Baltimore District Office CGMP for Foods/Seafood HACCP/Adulterated September 05, 2012
April 29, 2011 Standard Homeopathic Company, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
April 28, 2011 International Institute of Holistic Healing Inc. Dallas District Office New Drug/Misbranded Not Issued *



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