2001 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 2001

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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 July 23, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
August 27, 2001	Custom Pack, Inc.	New Orleans District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
August 27, 2001	Lee Memorial Health System	Florida District Office	Current Good Manufacturing Practices for Blood and Blood Components	N/A *
August 27, 2001	Equirace Health & Speed Products	Philadelphia District Office	New Animal Drugs/Extralabel Drug Use in Animals/Adulterated/Misbranded	N/A *
August 24, 2001	Corporate Aircraft Inc.	San Francisco District Office	Interstate Conveyance Sanitation Regulations	N/A *
August 24, 2001	Getinge/Castle, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Patient Lifts & Bath Systems/Adulterated	N/A *
August 24, 2001	United States Lines	San Francisco District Office	GMP in Manufacturing,Packing, or Holding Human Food/Interstate Conveyance Regulations	N/A *
August 24, 2001	Visalia Medical Clinic, Inc.	San Francisco District Office	Mammography Quality Standards	N/A *
August 23, 2001	Simmesport Fish Company	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
August 23, 2001	Coco's Seafood & Fish Company	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
August 23, 2001	Antique Mall Ltd.	New Orleans District Office	Seafood HACCP	N/A *
August 22, 2001	Comet Crawfish Technology, Inc.	New Orleans District Office	Seafood HACCP	N/A *
August 22, 2001	Baxter Healthcare Corp.	Chicago District Office	Quality System Regulation for Medical Devices/Infusion Pumps/Adulterated	N/A *
August 22, 2001	Prescott Imaging Center	Los Angeles District Office	Mammography Quality Standards	N/A *
August 22, 2001	Columbia/San Jose Breast Care Center	San Francisco District Office	Mammography Quality Standards	N/A *
August 22, 2001	Allergan, Inc.	Center for Biologics Evaluation and Research	Violative Promotion Advertising/Lacking Fair Balance/Misleading	N/A *
August 22, 2001	Zambales Bakery & Fast Food	Los Angeles District Office	Fish & Fishery Products Regulation/HACCP/Adulterated	N/A *
August 22, 2001	Ortho Development Corporation	Denver District Office	Quality System/Good Manufacturing Practice for Medical Devices Regulation/Orthopedic Implants	N/A *
August 22, 2001	Gourmet Express Marketing, Inc.	Chicago District Office	Seafood HACCP	N/A *
August 22, 2001	Kettle Cuisine, Inc.	New England District Office	Seafood HACCP/Seafood Chowders	N/A *
August 22, 2001	FHC - Moore Regional Hospital- Mobile	Atlanta District Office	Mammography Quality Standards	N/A *
August 21, 2001	Splintek-PP, Inc.	Center for Devices and Radiological Health	Premarket Notification Procedures/Not Substantially Equivalent/Adulterated/Misbranded	N/A *
August 21, 2001	Laborde Diagnostics- South College	New Orleans District Office	Mammography Quality Standards	N/A *
August 21, 2001	M. Slavin & Sons, Ltd.	New York District Office	Seafood HACCP	N/A *
August 21, 2001	Advance Radiological Center	Detroit District Office	Mammography Quality Standards	N/A *
August 21, 2001	Lentz, Meredith R., M.D.	Center for Devices and Radiological Health	Sponsor/Monitor/Contract Research Organization	N/A *
August 21, 2001	The Hyland Co., Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
August 21, 2001	Agroaltos, S.A.	Florida District Office	Snow Peas/Presented for Destruction are not the Original Product	N/A *
August 21, 2001	Shelby Baptist Medical Center	New Orleans District Office	Mammography Quality Standards	N/A *
August 21, 2001	Southern Aire Seafood, Inc.	New Orleans District Office	Seafood HACCP	N/A *
August 20, 2001	Greenville Loop Seafood	Atlanta District Office	Seafood HACCP	N/A *
August 17, 2001	Imaging Associates, Inc.	Atlanta District Office	Mammography Quality Standards	N/A *
August 17, 2001	Foods C'Est Bon, Limited	New Orleans District Office	Seafood HACCP	N/A *
August 17, 2001	Baker's Pharmacy	Chicago District Office	cGMP/Finished Pharmaceutical/Oxygen Repacking Facility/Adulterated	N/A *
August 17, 2001	Irvine Medical Center	Los Angeles District Office	Mammography Quality Standards	N/A *
August 17, 2001	Stewart-Jackson Pharmacal Inc.	New Orleans District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
August 17, 2001	Kingston Diagnostic Center	New York District Office	Mammography Quality Standards	N/A *
August 17, 2001	Holy Cross Hospital	Chicago District Office	GMP for Blood & Blood Components/Records & Reports	N/A *
August 17, 2001	Copley Feed & Supply	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
August 17, 2001	Daebok Restaurant	New York District Office	Seafood HACCP	N/A *
August 17, 2001	Oratec Interventions, Incorporated	Center for Devices and Radiological Health	Labeling/Premarket Notification Procedure/Adulterated/Misbranded	N/A *
August 16, 2001	Agri-Mark Farmers Co-op, Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
August 16, 2001	Mayco Fish Company, Ltd.	Seattle District Office	Seafood HACCP	N/A *
August 16, 2001	Oak Tree Farm Dairy, Inc.	New York District Office	Food Labeling/Misbranded	N/A *
August 16, 2001	St. Luke's Hospital	Minneapolis District Office	Mammography Quality Standards	N/A *
August 15, 2001	Les Laboratories Blanchard	Center for Devices and Radiological Health	Quality System Regulation/Contact Lenses/Adulterated	N/A *
August 15, 2001	Asian American Trading Co., Inc.	San Juan District Office	Seafood HACCP	N/A *
August 15, 2001	Clearly Canadian Beverage Corporation	Center for Food Safety and Applied Nutrition	Food Labeling/Misbranded	N/A *
August 14, 2001	The Imaging Center	Detroit District Office	Mammography Quality Standards	N/A *
August 14, 2001	Nose Breathe	Center for Devices and Radiological Health	Lacks Approved Premarket Application/Adulterated/Misbranded	N/A *
August 14, 2001	Tiao Peng Trading Company	San Francisco District Office	Fish Maw/Import Alert/Contains Filth Elements	N/A *

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