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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
04/13/2006 Japanese Food Express, Inc. [ARCHIVED] Detroit District Office Seafood HACCP/Adulterated N/A *
04/13/2006 Resonance Technology, Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
04/13/2006 Hardie Farms, Inc. [ARCHIVED] New York District Office Illegal Drug Residue N/A *
04/12/2006 Schell and Kampeter Inc. [ARCHIVED] Atlanta District Office Illegal Drug Residue/Adulterated/Misbranded N/A *
04/11/2006 Ocean Deep, LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
04/10/2006 Neurotone Systems, Inc [ARCHIVED] Dallas District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
04/07/2006 Cody Laboratories, Inc [ARCHIVED] Denver District Office Current Good Manufacturing Practices/Active Pharmaceuticals Ingredient/Adulterated N/A *
04/07/2006 Orthohelix Surgical Designs, Inc [ARCHIVED] Cincinnati District Office Qaulity System Regulation/Correction & Removal Regulation/Adulterated/Misbranded N/A *
04/07/2006 Ferno-Washington, Inc [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice/Medical Device Report Regulation/Adulterated N/A *
04/06/2006 McAdam Health Enterprises [ARCHIVED] Seattle District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
04/05/2006 Bold Coast Smokehouse [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
04/05/2006 Valentine, Joseph Philadelphia District Office Illegal Drug Residue N/A *
04/05/2006 Sam Rust Seafood Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
04/04/2006 Centro Estudios Radiologicos - Santurce Medical Mall [ARCHIVED] San Juan District Office Mammography Quality Standards Act N/A *
04/04/2006 Wilbur Ellis Company [ARCHIVED] Denver District Office New Animal Drug/Adulterated N/A *
04/03/2006 Royal Crest Dairy, Inc. [ARCHIVED] Denver District Office Juice HACCP/Adulterated N/A *
04/01/2006 EM Innovations, Inc [ARCHIVED] Cincinnati District Office Quality Systems Regulation/Adulterated N/A *
03/31/2006 Bonamar Corporation [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
03/30/2006 Karina Manufacturing Inc. [ARCHIVED] San Juan District Office Food Labeling/Misbranded N/A *
03/30/2006 EEMSO, Inc. [ARCHIVED] Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
03/29/2006 Kickapoo Orchard, Inc [ARCHIVED] Minneapolis District Office Juice HACCP/Adulterated N/A *
03/28/2006 ASK Foods, Inc [ARCHIVED] Philadelphia District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
03/27/2006 Boman, William [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
03/24/2006 VaxGen Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/False & Misleading Claims/Misbranded N/A *
03/23/2006 Royal Foods, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
03/23/2006 Mr. Fish Seafood [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
03/23/2006 MNC Pharmaceuticals Group, Inc [ARCHIVED] Philadelphia District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
03/22/2006 North American Herb & Spice [ARCHIVED] Chicago District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
03/21/2006 Ustov, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
03/21/2006 Fenster, Paul M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
03/20/2006 Southern Tier Plastics Inc [ARCHIVED] New York District Office QSR/Medical Devices/Adulterated N/A *
03/17/2006 Sea Breeze Fish Market Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
03/17/2006 In Vivo Metric Systems Corporation [ARCHIVED] San Francisco District Office GMP Requirement/Quality System Regulations/Medical Device Reporting N/A *
03/17/2006 Pacific Hi-Tak, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
03/17/2006 Jensen & Pilegard [ARCHIVED] San Francisco District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
03/17/2006 Agile Radiological Technologies, Inc. [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
03/16/2006 Daiei Trading Co., Inc [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
03/16/2006 PML Microbiologicals, Inc. [ARCHIVED] Seattle District Office Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
03/16/2006 FRM Chemical, Inc. [ARCHIVED] Kansas City District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
03/15/2006 B. Braun Medical Inc [ARCHIVED] Philadelphia District Office CGMP/Pharmacy Compounding/Insanitary Condition/Adulterated/Misbranded N/A *
03/15/2006 Ranieri Fine Food Corporation [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
03/15/2006 Lost Trail Dairy, LLC Dallas District Office Illegal Drug Residue N/A *
03/15/2006 Supreme Lobster & Seafood Co. [ARCHIVED] Chicago District Office Seafood HACCP/Adulterated N/A *
03/13/2006 General Atomics [ARCHIVED] Los Angeles District Office GMP Medical Device Reporting/Adulterated/Misbranded N/A *
03/13/2006 Global Healing Center [ARCHIVED] Dallas District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
03/10/2006 Bornstein Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
03/10/2006 The Women's Imaging Center [ARCHIVED] Dallas District Office Mammography Quality Standards N/A *
03/10/2006 Sea Port Trading Corporation [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
03/09/2006 Windy Ridge Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
03/09/2006 Community Blood Center of Greater Kansas City [ARCHIVED] Kansas City District Office Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated N/A *

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ICECI Warning Letters

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