2000 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 2000

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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 26, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 01, 2000	Crumbaker Pork LLC	Kansas City District Office	Medicated Feeds	N/A *
November 01, 2000	Merck & Co. Inc.	San Juan District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 31, 2000	Mountain Valley Fish & Oyster Inc.	Denver District Office	Seafood HACCP/Adulterated	N/A *
October 31, 2000	Northern Beef Products	Denver District Office	Edible Tissues/Adulterated	N/A *
October 30, 2000	American Stevedoring Inc.	New York District Office	Control of Communicable Disease and Interstate Conveyance Sanitation	N/A *
October 30, 2000	Spolana a.s.	Center for Drug Evaluation and Research	Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated/cGMP	N/A *
October 30, 2000	Gray & Cook P.S.C.	Cincinnati District Office	Mammography Standards	N/A *
October 30, 2000	Abkit Inc.	New York District Office	Alpha Betic Multi-Vitamin Supplement with Alpha Lipoic Acid/Labeling/Lacks NDA/Misbranded	N/A *
October 27, 2000	Eastern Plumas District Hospital	San Francisco District Office	Mammography Standards	N/A *
October 27, 2000	New York Marine Terminals	New York District Office	Control of Communicable Disease and Interstate Conveyance Sanitation	N/A *
October 27, 2000	Memorial Community Hospital	Dallas District Office	Mammography Standards	N/A *
October 27, 2000	Osteopathic Medical Center	Dallas District Office	Mammography Standards	N/A *
October 27, 2000	St. Paul Breast Center	Dallas District Office	Mammography Standards	N/A *
October 27, 2000	Presentation Medical Center-Mobile	Minneapolis District Office	Mammography Standards	N/A *
October 27, 2000	St. Paul Mobile Center-Mobile	Dallas District Office	Mammography Standards	N/A *
October 26, 2000	Georgetwon University Medical Center at Ballston	Baltimore District Office	Mammography Standards	N/A *
October 25, 2000	De La Pedraja Radiology Associates P.A.	Florida District Office	Mammography Standards	N/A *
October 25, 2000	Kyphone Incorporated	Center for Devices and Radiological Health	Quality System Regulation/Kyphon Inflatable Bone Tamp/Adultered/Misbranded	N/A *
October 24, 2000	Activa Brand Products	Center for Devices and Radiological Health	Quality System Regulation/Needleless Insulin Injectors	N/A *
October 24, 2000	Sea Lobster Company Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
October 24, 2000	National Home Products Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Sterile Adhesive Bandages	N/A *
October 24, 2000	Aurora Health Care Inc.	Minneapolis District Office	Mammography Standards	N/A *
October 24, 2000	Bill Forrest Seafood Co.	Baltimore District Office	Seafood Processing Regulations/HACCP	N/A *
October 23, 2000	Shallotte River Crab Company	Atlanta District Office	Seafood Processing Regulations/HACCP	N/A *
October 23, 2000	Baxa Corporation	Denver District Office	Quality System/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
October 23, 2000	Yorktown Diagnostic Imaging	New York District Office	Mammography Standards	N/A *
October 23, 2000	Oxarc Incorporated	Seattle District Office	Medical Oxygen / CGMP	N/A *
October 20, 2000	PSP Dental Company LTD.	Center for Devices and Radiological Health	Quality System Regulation/Dental Compounds	N/A *
October 20, 2000	Stoller Fisheries Division - Progressive Companies Inc.	Kansas City District Office	Seafood Processing Regulations/HACCP	N/A *
October 19, 2000	Community Blood Bank of the Lancaster County Medical Society	Kansas City District Office	Good Manufacturing Practices for Blood and Blood Products	N/A *
October 19, 2000	Pine Hill Trailways	New York District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
October 18, 2000	Sam Rust Seafood Inc.	Baltimore District Office	Seafood Processing Regulations/HACCP	N/A *
October 18, 2000	Midway Airlines Corp.	New York District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
October 17, 2000	Submaster	Minneapolis District Office	Seafood Processing Regulations/HACCP	N/A *
October 16, 2000	Obstetrics and Gynecology Associates P.A.	New Orleans District Office	Mammography Standards	N/A *
October 16, 2000	Ultratab Laboratories Inc.	New York District Office	Good Manufacturing Practices for Finished Pharmaceuticals	N/A *
October 16, 2000	Pan American Grain Mfg. Co. Inc.	San Juan District Office	Medicated Feeds/CGMP	N/A *
October 13, 2000	Neptune Sandwiches	Minneapolis District Office	Seafood Processing Regulations/HACCP	N/A *
October 13, 2000	Digibotics Inc.	Center for Devices and Radiological Health	Performance Standards for Light Emitting Products/Laser Products	N/A *
October 13, 2000	Mahoning Valley Imaging at Healthridge Medical Center	Cincinnati District Office	Mammography Standards	N/A *
October 13, 2000	Biotest AG	Office of Enforcement	Quality System Regulation	N/A *
October 13, 2000	Bio-Rad Laboratories Inc.	Office of Enforcement	Quality System Regulation	N/A *
October 13, 2000	Certified Grocers Midwest Inc.	Chicago District Office	Insanitary Conditions/Food Storage Warehouse	N/A *
October 12, 2000	Sun Nuclear Corp.	Florida District Office	Quality System Regulation/Adulterated/Misbranded	N/A *
October 12, 2000	Buffalo Welding Supply Co. Inc.	New York District Office	Medical Oxygen / CGMP	N/A *
October 12, 2000	MS Foods Inc.	Denver District Office	Sprouts/Adulterated	N/A *
October 12, 2000	Kanox Inc.	Denver District Office	GMP for Finished Pharmaceuticals/Oxygen USP/Adulterated	N/A *
October 12, 2000	Foods Galore Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
October 12, 2000	Northern Ohio Imaging Center	Cincinnati District Office	Mammography Standards	N/A *
October 11, 2000	Pardee Outpatient Radiology Center-Mobile	Atlanta District Office	Mammography Standards	N/A *

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