2005 Warning Letters

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Warning Letters issued in 2005

 

* 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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 17, 2005	Heritage Products International	Detroit District Office	Labeling and Promotional Violations	N/A *
October 17, 2005	Rowley's South Ridge Farms, Inc.	Denver District Office	Labeling/New Drug/False & Misleading Claims/Misbranded	N/A *
October 17, 2005	Flavonoid Sciences	Detroit District Office	Labeling and Promotional Violations	N/A *
October 17, 2005	Eden Foods, Inc.	Detroit District Office	Labeling and Promotional Violations	N/A *
October 17, 2005	Rowley and Hawkins Fruit Farm	Seattle District Office	Labeling and Promotional Violations	N/A *
October 14, 2005	BioHarmonics Research and Consulting	Atlanta District Office	Lacks Premarket Approval Application Misbranded	N/A *
October 14, 2005	Weese-Mayer, Debra E., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
October 13, 2005	Professional Hair Institute, Inc.	Baltimore District Office	Lacks Approved New Drug Application/Misbranded	N/A *
October 12, 2005	Niitikaya USA Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
October 12, 2005	B. Braun Medical Inc	New Jersey District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
October 11, 2005	Rowen, Sheri L., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
October 11, 2005	Buss, Merle R.	Dallas District Office	Illegal Drug Residue	N/A *
October 07, 2005	Dexter Dairy	Denver District Office	Illegal Drug Residue /Adulterated	N/A *
October 07, 2005	Roy and Malensky	Seattle District Office	Juice HACCP	N/A *
October 07, 2005	Mulingtapang, Reynaldo F. MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
October 07, 2005	Fisher's Homestyle Salads	Philadelphia District Office	Seafood HACCP/Adulterated	N/A *
October 06, 2005	September Enterprises, Inc.	Minneapolis District Office	Seafood HACCP/Adulterated	N/A *
October 06, 2005	Before and After Cosmetic LLC	New Jersey District Office	Labeling/New Drug/Misbranded	N/A *
October 05, 2005	Panbio, Inc.	Baltimore District Office	Lacks Premarket Approval Application/Misbranded	N/A *
October 05, 2005	Penn Herb Co Ltd.	Philadelphia District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *

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