2002 Warning Letters

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Warning Letters for 2002

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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

 

Posted on May 04, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 30, 2002	Swan River Fish Market	New England District Office	Seafood HACCP/Adulterated	N/A *
December 30, 2002	Vukman, Gerald R., D.V.M.	New York District Office	Illegal Tissue Residue/Extralabel Drug Use in Animals/Adulterated	N/A *
December 30, 2002	Reyncrest Farms, Inc.	New York District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
December 28, 2002	Diamond Pacific	Los Angeles District Office	CGMP for Licensed Medicated Feeds/Adulterated	N/A *
December 27, 2002	Searle, Ltd.	San Juan District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 27, 2002	Fischer Imaging Corporation	Denver District Office	Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
December 26, 2002	Boersma #2 Dairy	Los Angeles District Office	Illegal Edible Tissue Residue/Adulterated	N/A *
December 24, 2002	William M. Vargulick Dairy Farm	New York District Office	Illegal Drug Residue/Adulterated	N/A *
December 24, 2002	Hoover Feed Service, Inc.	Detroit District Office	New Drug/Adulterated	N/A *
December 23, 2002	Gambardella Wholesale Fish Dealers, Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
December 23, 2002	DBA Zacharias Holsteins	New England District Office	Drug in Edible Tissue/Extralabel Use/Adulterated	N/A *
December 20, 2002	McAnally Enterprises LLC	Los Angeles District Office	CGMP for Licensed Medicated Feeds/Adulterated	N/A *
December 20, 2002	Wallach Surgical Devices, Inc.	New England District Office	CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated	N/A *
December 20, 2002	Edward W. McCready Memorial Hospital	Baltimore District Office	Mammography Quality Standards	N/A *
December 20, 2002	Sunnyvale Seafood Corporation	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 19, 2002	Southwest Pharmacy/DBA Anchor Home Care	New Orleans District Office	CGMP/Oxygen Compressed/Adulterated	N/A *
December 19, 2002	Coulter Corporation	Office of Enforcement	GMP for Blood and Blood Products/Quality System Regulation	N/A *
December 19, 2002	Costa View Farms	San Francisco District Office	Illegal Edible Tissue Residue/Adulterated	N/A *
December 18, 2002	Vet Pharm, Inc.	Kansas City District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
December 18, 2002	Kraft Foods North America, Inc.	Chicago District Office	Food Standards/Cheese and Related Products/Misbranded	N/A *
December 18, 2002	Greater Miami Caterers Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
December 18, 2002	Gateway Blood Association	Kansas City District Office	Blood Products/Lacks Approved License for Interstate Commerce	N/A *
December 17, 2002	Eastern Medical Equipment Distributors, Inc.	Florida District Office	CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated	N/A *
December 17, 2002	Paul Ramer Construction	Detroit District Office	New Drug/Adulterated	N/A *
December 17, 2002	Minneapolis Radiology Associates, Ltd.	Minneapolis District Office	Mammography Quality Standards	N/A *
December 16, 2002	Gulf Medical Services	Florida District Office	CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated	N/A *
December 13, 2002	VBM Medizintechnik GMBH	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
December 12, 2002	Southern Herb Acquisition Co., LLC	Minneapolis District Office	New Drug/Misbranded	N/A *
December 12, 2002	Primary Care Plus	Atlanta District Office	Mammography Quality Standards	N/A *
December 12, 2002	Land O'Lakes	Kansas City District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
December 11, 2002	VISX Inc	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
December 11, 2002	Y & L Washington, Inc.	Seattle District Office	Seafood HACCP/Food Labeling/Adulterated/Misbranded	N/A *
December 11, 2002	Virginia Seafood, LLC	Baltimore District Office	Food Labeling/Misbranded	N/A *
December 11, 2002	Metropolitan Hospital Center	New York District Office	Mammography Quality Standards	N/A *
December 11, 2002	Beaumont Products, Inc.	Atlanta District Office	Unapproved New Drug/GMP for Finished Pharmaceuticals/Misbranded	N/A *
December 10, 2002	Serv-A-Pure Company	Detroit District Office	Quality System Regulation/Water Purification Systems/Adulterated	N/A *
December 10, 2002	Superior Uniform Group, Inc.	Dallas District Office	QSR/Lack Premarket Approval/Registration Listing/Adulterated/Misbranded	N/A *
December 09, 2002	Catholic Health Partners	Center for Biologics Evaluation and Research	IRB (Institutional Review Board)	N/A *
December 09, 2002	E.M. Adams Co., Inc.	Florida District Office	Quality System Reguation/Adulterated	N/A *
December 06, 2002	Walk, William M.	Chicago District Office	Edible Tissue/Adulterated	N/A *
December 06, 2002	Hobart Laboratories, Inc.	Chicago District Office	CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated	N/A *
December 06, 2002	E & M Corp	San Francisco District Office	Food Labeling/Misbranded	N/A *
December 06, 2002	Carib Import & Export, Inc.	Florida District Office	Seafood HACCP	N/A *
December 05, 2002	Desert Advanced Imaging Center	Los Angeles District Office	Mammography Quality Standards	N/A *
December 04, 2002	D.L. Mathews & Co. Inc.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
December 03, 2002	Classic Medical, Inc.	Detroit District Office	Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	N/A *
December 03, 2002	Medical Diagnostic Center (Southside)	Florida District Office	Mammography Quality Standards	N/A *
December 03, 2002	Herbal Remedies USA, LLC	Denver District Office	New Drugs/Misbranded	N/A *
December 02, 2002	Charles L. Earsing Dairy Farm	New York District Office	Illegal Tissue Residue/Extra-label Use/Adulterated	N/A *
December 02, 2002	Standard Tool & Die Inc.	New Orleans District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *

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