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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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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2005

 

* 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 13, 2005 CEPH International Corporation San Juan District Office CGMP/Adulterated N/A *
September 09, 2005 Ada Veterinary Clinic, Inc. Dallas District Office Illegal Drug Residue /Adulterated N/A *
September 08, 2005 Seattle Fish Company, Inc. Kansas City District Office Seafood HACCP/Adulterated N/A *
September 07, 2005 Parker, Norva R Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
September 07, 2005 Electro Medical, Inc. Dallas District Office Current Good Manufacturing Practice/Adulterated N/A *
September 07, 2005 Xtreme Design, Inc. Minneapolis District Office Lacks New Animal Drug Application N/A *
September 06, 2005 Endurance Products Company, Inc. Seattle District Office Promotional Claims False & Misleading/New Drugs N/A *
September 01, 2005 Sunburst Trout Company, LLC Atlanta District Office Seafood HACCP/Adulterated N/A *
August 31, 2005 Octapharma USA, Inc. Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
August 31, 2005 Mackie International, Inc. Los Angeles District Office False & Misleading Claims/Misbranded N/A *
August 31, 2005 Providence Dairy Denver District Office Illegal Drug Residue /Adulterated N/A *
August 30, 2005 Beverly Hills Prostetics Orthotics, Inc. Los Angeles District Office Current Good Manufacturing Practice/Adulterated N/A *
August 30, 2005 Ulrich GmbH & Co. KG Center for Devices and Radiological Health Current Good Manufacturing Practice/adulterated/misbranded N/A *
August 26, 2005 Tepnel Diagnostics Ltd. Center for Devices and Radiological Health Lacks Premarket Approval Application Adulterated N/A *
August 25, 2005 Efoora, Inc. Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
August 25, 2005 Saliva Diagnostic Systems, Inc. Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
August 25, 2005 Southern Implants, LLC Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 25, 2005 A Perfect Food Company, LLC Florida District Office Promotional Claims/New Drug/Misbranded N/A *
August 25, 2005 Bowerman, Freddie J. & Letitia Dallas District Office Illegal Drug Residue /Adulterated N/A *
August 25, 2005 Alpha Omega Manufacturing, Inc. Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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