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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
September 21, 2006 IVF Michigan P.C. [ARCHIVED] Detroit District Office Human Cells, Tissues & Cellular Products N/A *
September 21, 2006 Optimal Wellness Center [ARCHIVED] Chicago District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
September 21, 2006 Berkline, LLC [ARCHIVED] New Orleans District Office CGMP for Medical Devices/Adulterated N/A *
September 20, 2006 Xango LLC, Intl [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
September 20, 2006 Xango LLC, International [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading N/A *
September 19, 2006 Will-O-Crest Farms, LP New York District Office Illegal Drug Residue N/A *
September 18, 2006 Central Boeki California, Ltd [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
September 18, 2006 North, Lloyd New York District Office Illegal Drug Residue N/A *
September 15, 2006 Dialysis Services, Inc. [ARCHIVED] New Orleans District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
September 14, 2006 Zaharowitz, Herman, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
September 12, 2006 Matheson Tri-Gas, Inc. [ARCHIVED] Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
September 11, 2006 Patriot Foods LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
September 08, 2006 Hawkins, Inc. [ARCHIVED] Minneapolis District Office CGMP Active Pharmaceutical Ingredient N/A *
September 08, 2006 Zeis, Fred J Minneapolis District Office Illegal Drug Residue N/A *
September 07, 2006 Ramona's Mexican Food Products, Inc. [ARCHIVED] Los Angeles District Office Food / Insanitary Conditions N/A *
September 07, 2006 Boston Salads & Provisions Co., Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
September 06, 2006 ALK-Abello, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims False & Misleading/Misbranded N/A *
September 05, 2006 Carribean Conch, Inc. [ARCHIVED] Florida District Office Adulterated Seafood HACCP N/A *
September 05, 2006 Biolase Technology, Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
September 05, 2006 Smith Medical Critical Care, Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/Adulterated N/A *
August 31, 2006 Grupo Gloria/Suiza Dairy [ARCHIVED] San Juan District Office Food Labeling/Misbranded N/A *
August 31, 2006 Frye Health Systems, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice/Adulterated N/A *
August 31, 2006 Moon Glow Dairy San Francisco District Office Illegal Drug Residue N/A *
August 31, 2006 Terumo Cardiovascular Systems [ARCHIVED] Detroit District Office Quality System Regulations for Medical Device Reporting/Misbranded N/A *
August 30, 2006 Oregon Ocean Seafoods [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
August 29, 2006 LGS Technologies, LP [ARCHIVED] Dallas District Office CGMP for Medical Devices/Adulterated N/A *
August 29, 2006 Medtronic, Inc. [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/Adulterated N/A *
August 28, 2006 Chien Ti Enterprise Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
August 28, 2006 John Potter Farm, LLC [ARCHIVED] New England District Office Illegal Drug Residue N/A *
August 22, 2006 Ming Hong International, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
August 22, 2006 Eppley, Barry L., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
August 18, 2006 Ostroumova, Olga D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
August 18, 2006 Columbus Fish and Seafood, LLC [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated N/A *
August 18, 2006 Everett Fisheries, Inc. [ARCHIVED] Minneapolis District Office Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
August 17, 2006 Ridley, Inc. [ARCHIVED] Kansas City District Office CGMP Requirements For Medicated Feeds/Adulterated N/A *
August 17, 2006 MPM Farms Kansas City District Office Illegal Drug Residue N/A *
August 17, 2006 Command Medical Products [ARCHIVED] Florida District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
August 17, 2006 Berwald Dairy Minneapolis District Office Illegal Drug Residue N/A *
August 17, 2006 The Service Center [ARCHIVED] Chicago District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
August 14, 2006 Vreba-Hoff Dairy, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
August 14, 2006 Hamrick's LLC [ARCHIVED] Los Angeles District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
August 14, 2006 Black Henna Ink, Inc. [ARCHIVED] Florida District Office Color Additive/Adulterated N/A *
August 14, 2006 Merial Limited [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading N/A *
August 11, 2006 Pointe Scientific Inc [ARCHIVED] Detroit District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
August 10, 2006 J & S Distribution and Trading, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
August 09, 2006 Meech, Todd R. Minneapolis District Office Illegal Drug Residue N/A *
August 09, 2006 Rotech Healthcare, Inc [ARCHIVED] Cincinnati District Office Pharmacy Compounding/Unapproved New Drug/Misbranded N/A *
August 09, 2006 Pascal Company, Inc. [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
August 09, 2006 CCS Medical [ARCHIVED] Florida District Office Pharmacy Compounding/Unapproved New Drug/Misbranded N/A *
August 08, 2006 Sonotech, Incorporated [ARCHIVED] Seattle District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *

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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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