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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

 
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 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 Medtronic Vascular Center for Devices and Radiological Health Sponsor Obligations N/A *
September 27, 2006 Home Acres Farm New England District Office Illegal Drug Residue 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 Berkline, LLC New Orleans District Office CGMP for Medical Devices/Adulterated N/A *
September 21, 2006 IVF Michigan P.C. Detroit District Office Human Cells, Tissues & Cellular Products N/A *
September 21, 2006 Cayenne Company, Onc. Minneapolis District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
September 21, 2006 Optimal Wellness Center Chicago District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
September 21, 2006 Thermoplastic Comfort Systems, Inc. Los Angeles District Office Current Good Manufacturing Practice for Medical Devices/Adulterated 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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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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Rockville, MD 20857
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