2003 Warning Letters

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Warning Letters issued in 2003

 

* 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

 

Posted on June 30, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
June 30, 2003	Canadian Discount Drugs	Center for Drug Evaluation and Research	Illegal Canadian Drug Importation	N/A *
June 27, 2003	Interland Seafood Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
June 26, 2003	T & W Dairy	Los Angeles District Office	Illegal Drug Residue/Animal Tissue/Adulterated	N/A *
June 25, 2003	Weinberger Appetizing	New York District Office	Seafood HACCP/Adulterated	N/A *
June 25, 2003	UHHS-Richmond Heights Hospital	Cincinnati District Office	Mammography Quality Standards	N/A *
June 25, 2003	Burma, Gerald M., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 24, 2003	Zimmer Elektromedizin GMBH	Center for Devices and Radiological Health	Lacks Pre-Market Notification/Quality System Regulation/Adulterated/Misbrandeded	N/A *
June 24, 2003	Jaye, Cheryl Jones, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 23, 2003	Allergan, Inc.	Center for Biologics Evaluation and Research	BOTOX/False & Misleading Material/Misbranded	N/A *
June 23, 2003	Indumar Seafood Corporation	Florida District Office	Seafood HACCP/Adulterated	N/A *
June 23, 2003	K&W Trading, Inc.	Chicago District Office	Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated	N/A *
June 23, 2003	Sierra Vista Dairy	San Francisco District Office	Illegal Drug Residue Animal Tissue/Adulterated	N/A *
June 20, 2003	Seaside Fish Company	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
June 19, 2003	Drew Medical, Inc	Florida District Office	Mammography Quality Standards	N/A *
June 19, 2003	Criado, Frank J. M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 18, 2003	Variety Food Services, LLC	Cincinnati District Office	Good Manufacturing Practice requirements for foods/Adulterated	N/A *
June 18, 2003	Stevenson, William, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 18, 2003	Bioscan, Inc.	Denver District Office	Premarket Notification/Quality System Regulation/Adulterated	N/A *
June 17, 2003	Bobbery Enterprises Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
June 17, 2003	Tuna Express Company	Los Angeles District Office	Seafood HACCP/CGMP Manufacturing, Packing or Holding Human Food/Adulterated	N/A *
June 17, 2003	Piazza, Michael R., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 16, 2003	Individual Monitoring Systems, Inc.	Baltimore District Office	Quality System Regulation/Adulterated	N/A *
June 12, 2003	University Imaging Center LLC	Baltimore District Office	Mammography Quality Standards	N/A *
June 11, 2003	Daniel Freeman Marina Hospital	Los Angeles District Office	Mammography Quality Standards	N/A *
June 11, 2003	U.O. Equipment Company	Dallas District Office	Quality System Regulation/Good Manufacuring Practice/Medical Devices/Adulterated	N/A *
June 11, 2003	Rolling Acres Farm	Atlanta District Office	Illegal Drug Residue Animal Tissue/Adulterated	N/A *
June 11, 2003	Roche Diagnostics Corporation	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
June 10, 2003	BuyCoralCalcium.com	Center for Food Safety and Applied Nutrition	Drug Labeling/Promotional Claims/Misbranded	N/A *
June 10, 2003	1 Coral Calcium/Thin America	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
June 10, 2003	Regency Medical Research, Ltd	Los Angeles District Office	New Drug/False Promotional Statements/Misbranded	N/A *
June 10, 2003	Advantage Products	Center for Food Safety and Applied Nutrition	Dietary Supplements/Food Labeling/Misbranded	N/A *
June 10, 2003	Larsen's Bakery, Inc.	Minneapolis District Office	Food Labeling/Misbranded	N/A *
June 10, 2003	Haines, Peggy	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
June 10, 2003	Baltimore City, Transportation Maintenance Division	Baltimore District Office	Control of Communicable Diseases/Interstate Conveyance Sanitation	N/A *
June 09, 2003	Johnson, Steve	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
June 09, 2003	Nicholas Pharmacy Inc.	Baltimore District Office	Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	N/A *
June 09, 2003	Meragenesis Health Products	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
June 09, 2003	Joy Processed Food, Inc.	Los Angeles District Office	Good Manufacturing Practice Regulations for Human Foods/adultered	N/A *
June 09, 2003	Cabados, Rick	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
June 09, 2003	US Health Supplements	Center for Food Safety and Applied Nutrition	Misleading Promotional Materials	N/A *
June 09, 2003	Gonsalves, Brian	Center for Food Safety and Applied Nutrition	Dietary Supplement Lableing/False & Misleading Claims/Misbranded	N/A *
June 09, 2003	RedZone Global	Center for Food Safety and Applied Nutrition	Misleading Promotional Materials	N/A *
June 09, 2003	Davie County Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
June 09, 2003	Brunner Professional Services	Center for Food Safety and Applied Nutrition	Misleading Promotional Materials	N/A *
June 06, 2003	Ocean Beauty Seafoods, Inc.	Denver District Office	Seafood HACCP/Adulterated	N/A *
June 05, 2003	Norfolk Medical Products, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
June 05, 2003	Stewart, Ronnie R.	Minneapolis District Office	Drug Residue in Edible Animal Tissue/Adulterated	N/A *
June 05, 2003	Bobarosa's Gourmet Inc	Florida District Office	Good Manufacturing Practices for Acidified Foods/Emergency Permit Control Regulations	N/A *
June 03, 2003	Jamestown Regional Medical Center	New Orleans District Office	Mammography Quality Standards	N/A *
June 03, 2003	Endomed, Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *

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