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2005 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
October 11, 2005 Buss, Merle R. [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
October 07, 2005 Roy and Malensky [ARCHIVED] Seattle District Office Juice HACCP N/A *
October 07, 2005 Mulingtapang, Reynaldo F. MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 07, 2005 Dexter Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
October 07, 2005 Fisher's Homestyle Salads [ARCHIVED] Philadelphia District Office Seafood HACCP/Adulterated N/A *
October 06, 2005 September Enterprises, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
October 06, 2005 Before and After Cosmetic LLC [ARCHIVED] New Jersey District Office Labeling/New Drug/Misbranded N/A *
October 05, 2005 Penn Herb Co Ltd. [ARCHIVED] Philadelphia District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
October 05, 2005 Panbio, Inc. [ARCHIVED] Baltimore District Office Lacks Premarket Approval Application/Misbranded N/A *
October 04, 2005 HemoSense Corporation [ARCHIVED] San Francisco District Office Medical Device Reporting/Misbranded N/A *
October 04, 2005 Blood Bank of the Redwoods [ARCHIVED] San Francisco District Office Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components/adulterated N/A *
October 04, 2005 Highland Laboratories, Inc. [ARCHIVED] Seattle District Office Lacks Approved New Drug Application N/A *
October 03, 2005 Ross, Michelle A. MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
October 03, 2005 Callahan Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
October 01, 2005 Payson Fruit Growers, Inc. [ARCHIVED] Denver District Office Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
September 30, 2005 Phillip & Vincent Banks Dairy Farm [ARCHIVED] New Orleans District Office Illegal Drug Residue N/A *
September 30, 2005 Syntee Scientific Corp. [ARCHIVED] Center for Devices and Radiological Health CGMP Medical Device Reporting/Adulterated/Misbranded N/A *
September 30, 2005 Lobob Laboratories Inc. [ARCHIVED] San Francisco District Office CGMP Requirement of the Quality System Regulation for Medical Device N/A *
September 29, 2005 Pleasant View Farms, Inc. [ARCHIVED] Philadelphia District Office Illegal Drug Residue /Adulterated N/A *
September 29, 2005 Healthwest Mineral [ARCHIVED] Seattle District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
September 29, 2005 Boston Seafood Wholesale LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
September 29, 2005 Canada Food Outlet, Inc. [ARCHIVED] Chicago District Office Seafood HACCP N/A *
September 29, 2005 Smith Incredibull Farms [ARCHIVED] Philadelphia District Office Illegal Drug Residue /Adulterated N/A *
September 29, 2005 Parent, J. Rex, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
September 28, 2005 Nephron Pharmaceuticals Corp [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Postmarketing Adverse Drug Experience/Adulterated N/A *
September 28, 2005 Bayou City Fish Co, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
September 28, 2005 Silver Spring Farm Buffalo District Office Illegal Drug Residue N/A *
September 28, 2005 Sunshine Packing & Noodle Co., Inc [ARCHIVED] Florida District Office Labeling/Misbranded N/A *
September 27, 2005 Tyco Healthcare Group [ARCHIVED] San Francisco District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
September 27, 2005 Hawk Vending Services, Incorporated [ARCHIVED] Seattle District Office Seafood HACCP N/A *
September 27, 2005 Flathead Fish and Seafood Company [ARCHIVED] Seattle District Office Seafood HACCP N/A *
September 25, 2005 Hydroderm [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug N/A *
September 22, 2005 Sunrise Ocrhards, Inc. [ARCHIVED] Detroit District Office Juice HACCP/Adulterated N/A *
September 22, 2005 The Old Path Natural Herbs Inc [ARCHIVED] Florida District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
September 21, 2005 Chosen Valley Veterinary Clinic [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
September 21, 2005 Houchin Blood Services [ARCHIVED] San Francisco District Office Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated N/A *
September 20, 2005 Clem's Seafood & Specialities, Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/Adulterated N/A *
September 16, 2005 Merchants Distributors, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
September 16, 2005 ReGen Biologics [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
September 16, 2005 Bennett Industries, Incorporated [ARCHIVED] Nashville District Office Current Good Manufacturing Practice for Medical Devices N/A *
September 15, 2005 Macan Engineering and Manufacturing Company Inc. [ARCHIVED] Chicago District Office Quality System Regulation for Medical Devices/Adulterated/Misbranded N/A *
September 15, 2005 IFC International [ARCHIVED] Chicago District Office Medical Devices/Adulterated/Misbranded N/A *
September 15, 2005 R & L Farms [ARCHIVED] Atlanta District Office Illegal Drug Residue N/A *
September 14, 2005 Seafood Express, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
September 14, 2005 ConAgra Frozen Foods, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
September 13, 2005 A & H Farms [ARCHIVED] Atlanta District Office Illegal Drug Residue N/A *
September 13, 2005 Double D Seafood Company LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
September 13, 2005 Visual Telecommunications Network, Inc. [ARCHIVED] Baltimore District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
September 13, 2005 W & T Seafood Corp. [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
September 13, 2005 CEPH International Corporation [ARCHIVED] San Juan District Office CGMP/Adulterated N/A *

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ICECI Warning Letters

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