2006 Warning Letters

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Warning Letters issued in 2006

 

* 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 12, 2006	Hale Wai Oia, LLC	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Goldberg, David	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Progessive Health Nutraceuticals, Inc.	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Albano, Brenda	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	MicroNutraHealth	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Annie Rose, Inc.	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Pulsecast Ineractive Corp	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 12, 2006	Lein, David A., MD	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
October 12, 2006	Radiometer America, Inc.	Cincinnati District Office	Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation	N/A *
October 12, 2006	NATR, Inc	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 11, 2006	International Brachytherapy s.a.	Center for Devices and Radiological Health	CGMP for Medical Device Reporting/Adulterated	N/A *
October 11, 2006	NeuroScience, Inc.	Minneapolis District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
October 10, 2006	Harry O. Hahn Seafood	Philadelphia District Office	CGMP for Foods/Seafood HACCP	N/A *
October 04, 2006	Dairy Veterinary Services, P.A.	New England District Office	Illegal Drug Residue	N/A *
October 03, 2006	Morgan, Steven J., MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
October 02, 2006	Supreme Manufacturing Company, Inc.	New Jersey District Office	CGMP for Foods/Seafood HACCP/Adulterated/Misbranded	N/A *
October 02, 2006	Ray/Col Inc.	New England District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
October 02, 2006	Qiagen GmbH	Center for Devices and Radiological Health	Lacks Premarket Approval Application Misbranded	N/A *
October 01, 2006	Schoenberg, John W.	Minneapolis District Office	Illegal Drug Residue /Adulterated	N/A *
September 28, 2006	Banner Pharmacaps, Inc.	Atlanta District Office	Drug Manufacturing Operations/CGMP deviations	N/A *

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