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U.S. Department of Health and Human Services

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2006 Warning Letters

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Tobacco Retailer Warning Letters

 

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* 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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 21, 2006 Natren Inc. [ARCHIVED] Los Angeles District Office Labeling/Promotional Claims False & Misleading/Misbranded/Adulterated N/A *
November 19, 2006 Sanochemia Pharmazeutika AG [ARCHIVED] Center for Biologics Evaluation and Research Quality System Regulation N/A *
November 17, 2006 Crabs, LLC [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
November 16, 2006 Pride of the South Catfish, Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
November 15, 2006 Aqueous Biomedical, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
November 15, 2006 Evanston Regional Hospital [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
November 14, 2006 Vermeer Dairy Seattle District Office Illegal Drug Residue N/A *
November 14, 2006 Sea Port Products Corporation [ARCHIVED] San Francisco District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
November 14, 2006 New England Lobster Company Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
November 14, 2006 Shin Hwa Wholesale Distributor, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
November 13, 2006 Becton Dickinson and Co [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 13, 2006 Gerald Thompson Farm [ARCHIVED] Buffalo District Office Illegal Drug Residue N/A *
November 13, 2006 Gyrus ENT, LLC [ARCHIVED] New Orleans District Office CGMP Requirements of the Quality System Regulations/Adulterated N/A *
November 09, 2006 Delta Regional Medical Center [ARCHIVED] New Orleans District Office Mammography Quality Standards Act N/A *
November 09, 2006 Nelson, Douglas Jr. [ARCHIVED] New England District Office Illegal Drug Residue N/A *
November 09, 2006 Lakeview Farms, Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/Adulterated N/A *
November 08, 2006 UCA, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 08, 2006 Bartholomew, Bradley J., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
November 07, 2006 Schworer, Philip B. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
November 07, 2006 Mercy Mount Clemens Corporation [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
November 06, 2006 New England Smoked Seafood [ARCHIVED] New England District Office CGMP for Foods/HACCP N/A *
November 06, 2006 Pierpont Seafood [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
November 03, 2006 Lawrence, E Clinton MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
November 03, 2006 Benchmark Medical, Inc. [ARCHIVED] Denver District Office Labeling/OTC Human Use/New Drug/Misbranded N/A *
November 02, 2006 Country Maid, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/False & Misleading/Claims Misbranded N/A *
November 02, 2006 Direct Dispensing, Inc. [ARCHIVED] Florida District Office Labeling/OTC Human Use/New Drug/Misbranded N/A *
November 02, 2006 Perkins Electronics Company [ARCHIVED] Dallas District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
November 01, 2006 M & S Acquisition [ARCHIVED] Cincinnati District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
November 01, 2006 Williams Seafood of Arapahoe Inc. [ARCHIVED] Atlanta District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 31, 2006 Wedgewood Village Pharmacy [ARCHIVED] New Jersey District Office Pharmacy Compounding/New Drug/Misbranded N/A *
October 31, 2006 Dr. Steven K. Sue, D.D.S., M.S., Inc. [ARCHIVED] San Francisco District Office CGMP Requirements of Medical Device Reporting/Misbranded/Adulterated N/A *
October 31, 2006 Key of Destiny [ARCHIVED] San Francisco District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 31, 2006 Bausch & Lomb [ARCHIVED] Atlanta District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
October 31, 2006 Grandview Dairy LLC Seattle District Office Illegal Drug Residue N/A *
October 27, 2006 Bonita's Pizza, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
October 27, 2006 Wyldewood Cellars, Inc. [ARCHIVED] Kansas City District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 27, 2006 Shells & Fish Import and Export Co. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
October 26, 2006 H.J. Baker & Bro., Inc. [ARCHIVED] New Orleans District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
October 26, 2006 Northwest Order Buyers, Inc. Kansas City District Office Illegal Drug Residue N/A *
October 24, 2006 Patterson Technology Center, Inc. [ARCHIVED] Chicago District Office CGMP Requirements of Medical Device Reporting/Misbranded/Adulterated N/A *
October 24, 2006 Memorial Medical Center [ARCHIVED] Minneapolis District Office Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated N/A *
October 24, 2006 MotherSOY(R), Inc. [ARCHIVED] Detroit District Office Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded N/A *
October 23, 2006 Ellsworth Farm [ARCHIVED] New York District Office Illegal Drug Residue N/A *
October 23, 2006 Nutronix International [ARCHIVED] Baltimore District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 23, 2006 LaBore Seafood Ltd. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP N/A *
October 23, 2006 North Atlantic Traders Ltd [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 19, 2006 Memorial Hermann-Texas Medical Center [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
October 18, 2006 Churchill Veterinary Supply Company, Inc. [ARCHIVED] Cincinnati District Office Labeling/New Animal Drug/Adulterated/Misbranded N/A *
October 17, 2006 All Sea's Seafood of Florida, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
October 16, 2006 Sylomar Phytoceuticals [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *

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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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