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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
September 11, 2009 La Hacienda Tortilleria Inc New Orleans District Office CGMP Regulation For Food/Adulterated Not Issued *
September 11, 2009 Schlegel Dairy Farms Inc Cincinnati District Office Illegal Drug Residue Not Issued *
September 11, 2009 Luv N' Care Ltd New Orleans District Office Medical Devices/Adulterated/Misbranded Not Issued *
September 11, 2009 NETPRODUCTSTORE INC, DBA Afton Communications Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
September 10, 2009 United Metro Distribution Co. 9/10/09 Detroit District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
September 10, 2009 Pelican Packers, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 10, 2009 Baxter Healthcare Corp. Chicago District Office Medical Devices/Adulterated/Misbranded April 05, 2012
September 09, 2009 Lloyd T. Smith & Sons New York District Office Illegal Drug Residue Not Issued *
September 09, 2009 Border Foods, Incorporated Denver District Office Acidified Foods/Adulterated December 01, 2010
September 09, 2009 Witmer Foods, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated June 08, 2011
September 09, 2009 Ferris, Henry J. New York District Office Illegal Drug Residue Not Issued *
September 09, 2009 Szarek, Francis J New York District Office Illegal Drug Residue Not Issued *
September 04, 2009 Gambro Dialysatoren, GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
September 04, 2009 Pressure-Tech, Inc. New York District Office Premarket Approval/Misbranded/Adulterated Not Issued *
September 03, 2009 Pantheon Research 9/3/09 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
September 03, 2009 Supplements To WeightLoss, LLC Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
September 02, 2009 Solafeet, Inc Center for Devices and Radiological Health Radiological Health/Records & Report/Performance Standards Not Issued *
September 01, 2009 Beekman Foods Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated April 15, 2010
September 01, 2009 WHB Cattle LLC 9/1/09 Dallas District Office Illegal Drug Residue Not Issued *
August 31, 2009 Therasage, LLC. Florida District Office Medical Devices/Adulterated/Misbranded N/A *



 

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