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
September 28, 2006	Wolf, Randall K., MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
September 27, 2006	Radiometer Medical Aps	Center for Devices and Radiological Health	Good Manufacturing Practices / Quality System Regulations	N/A *
September 27, 2006	Home Acres Farm	New England District Office	Illegal Drug Residue	N/A *
September 27, 2006	Medtronic Vascular	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
September 27, 2006	Softlens Technology	Atlanta District Office	Device/Lacks Approved Premarket Application/Adulterated/Misbranded	N/A *
September 27, 2006	EP Medsystems	New Jersey District Office	CGMP Requirements of Medical Device Reporting/Misbranded/Adulterated	N/A *
September 27, 2006	Hebron International, Inc.	Atlanta District Office	Device Lacks Marketing Clearance Approval/Adulterated/Misbranded	N/A *
September 26, 2006	Catso Corp.	New York District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
September 22, 2006	Tucson Fruit and Produce	Dallas District Office	Seafood HACCP/Adulterated	N/A *
September 22, 2006	Professional Pad Printing Supply	Center for Devices and Radiological Health	Performance Standards for Light Emitting Products	N/A *
September 21, 2006	Optimal Wellness Center	Chicago District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
September 21, 2006	Berkline, LLC	New Orleans District Office	CGMP for Medical Devices/Adulterated	N/A *
September 21, 2006	Thermoplastic Comfort Systems, Inc.	Los Angeles District Office	Current Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
September 21, 2006	Cayenne Company, Onc.	Minneapolis District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
September 21, 2006	IVF Michigan P.C.	Detroit District Office	Human Cells, Tissues & Cellular Products	N/A *
September 20, 2006	Xango LLC, International	Denver District Office	Labeling/Promotional Claims False & Misleading	N/A *
September 20, 2006	Xango LLC, Intl	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
September 19, 2006	Will-O-Crest Farms, LP	New York District Office	Illegal Drug Residue /Adulterated	N/A *
September 18, 2006	Central Boeki California, Ltd	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
September 18, 2006	North, Lloyd	New York District Office	Illegal Drug Residue /Adulterated	N/A *

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