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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 17, 2010 White Egret, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Bobalee Originals Manufacturing Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Indian Mountain Center Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 A.J.'s Candles, Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Harmony Cone Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wholistic Health Solutions Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 International Ear Candle, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wally's Natural Products, Inc. San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Home Remedies Solutions Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 King Cone International Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Body Tools Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 16, 2010 Nature'S Gift Inc Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus Not Issued *
February 16, 2010 Songkla Canning Public Company Limited Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
February 16, 2010 Gourmet Express Marketing, Inc. Chicago District Office Seafood HACCP/CGMP/Misbranded Not Issued *
February 16, 2010 Biological Controls New Jersey District Office CGMP/QSR/Adulterated/Misbranded June 15, 2011
February 16, 2010 Crestview Calves, Inc. Seattle District Office Illegal Drug Residue Not Issued *
February 16, 2010 La Mexicana, Inc. Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
February 12, 2010 Wu, Helen K. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded July 29, 2011
February 12, 2010 LCA Vision Inc/Lasik Plus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded August 16, 2011
February 12, 2010 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 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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