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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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Tobacco Retailer 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 15, 2006 Dialysis Services, Inc. New Orleans District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
September 14, 2006 Zaharowitz, Herman, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
September 12, 2006 Matheson Tri-Gas, Inc. Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
September 11, 2006 Patriot Foods LLC Florida District Office Seafood HACCP/Adulterated N/A *
September 08, 2006 Hawkins, Inc. Minneapolis District Office CGMP Active Pharmaceutical Ingredient N/A *
September 08, 2006 Zeis, Fred J Minneapolis District Office Illegal Drug Residue /Adulterated N/A *
September 07, 2006 Ramona's Mexican Food Products, Inc. Los Angeles District Office Food / Insanitary Conditions N/A *
September 07, 2006 Boston Salads & Provisions Co., Inc. New England District Office Seafood HACCP/Adulterated N/A *
September 06, 2006 ALK-Abello, Inc. Center for Biologics Evaluation and Research Promotional Claims False & Misleading/Misbranded N/A *
September 05, 2006 Biolase Technology, Inc. Los Angeles District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
September 05, 2006 Carribean Conch, Inc. Florida District Office Adulterated Seafood HACCP N/A *
September 05, 2006 Smith Medical Critical Care, Inc. Cincinnati District Office CGMP for Medical Devices/Adulterated N/A *
August 31, 2006 Grupo Gloria/Suiza Dairy San Juan District Office Food Labeling/Misbranded N/A *
August 31, 2006 Moon Glow Dairy San Francisco District Office Illegal Drug Residue /Adulterated N/A *
August 31, 2006 Terumo Cardiovascular Systems Detroit District Office Quality System Regulations for Medical Device Reporting/Misbranded N/A *
August 31, 2006 Frye Health Systems, Inc. Dallas District Office Current Good Manufacturing Practice/Adulterated N/A *
August 30, 2006 Oregon Ocean Seafoods Seattle District Office Seafood HACCP/Adulterated N/A *
August 29, 2006 LGS Technologies, LP Dallas District Office CGMP for Medical Devices/Adulterated N/A *
August 29, 2006 Medtronic, Inc. Minneapolis District Office CGMP for Medical Devices/Adulterated N/A *
August 28, 2006 John Potter Farm, LLC New England District Office Illegal Drug Residue 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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