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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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

Posted on November 30, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 10, 2010 Friz-it Cold Storage, Inc. Florida District Office Seafood HACCP Not Issued *
November 10, 2010 Kabco Pharmaceuticals, Inc. New York District Office CGMP in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 10, 2010 Eagle Products Chicago District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated April 04, 2012
November 09, 2010 Ultimate Formulations, Inc. dba Best Formulations Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 09, 2010 Gunnell, Inc. Detroit District Office Premarket Approval/Adulterated/Misbranded March 18, 2013
November 09, 2010 Monarch Labs, LLC Los Angeles District Office CGMP for Medical Devices/QS/Adulterated April 03, 2012
November 09, 2010 Lsg Sky Chefs, Inc Dallas District Office Seafood HACCP Not Issued *
November 09, 2010 Race Street Foods, Inc San Francisco District Office Seafood HACCP Not Issued *
November 09, 2010 Monarch Labs, LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 08, 2010 Fish Cove, Inc. New York District Office Seafood HACCP Not Issued *
November 08, 2010 Pastime Lakes Dairy Los Angeles District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
November 08, 2010 Swedish Bitters Herbs Company Kansas City District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated" Not Issued *
November 08, 2010 Anchor Products Company, Inc Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded October 27, 2011
November 08, 2010 Zooscape.com New York District Office Unapproved New Drug Not Issued *
November 08, 2010 Tony Crab King, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 17, 2011
November 08, 2010 Soma Labs, Inc. New Jersey District Office Dietary Supplement/Adulterated June 08, 2011
November 05, 2010 Minnesota Smoothies And More, LLC. Minneapolis District Office Food Labeling Misbranded October 17, 2011
November 04, 2010 Inland Meats, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated September 19, 2011
November 03, 2010 Energy Technology Development Ltd./Wicked Lasers Center for Devices and Radiological Health Quality Control & Testing Program Not Issued *
November 03, 2010 Fish Brothers, Inc. San Francisco District Office Seafood HACCP Not Issued *


 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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