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
February 02, 2000	Vysis Inc.	Center for Devices and Radiological Health	Aneu Vysion Assay/Lacks Premarket Approval/Misbranded	N/A *
February 01, 2000	South Beach Beverage Company	Center for Food Safety and Applied Nutrition	Food Labeling/Beverage	N/A *
February 01, 2000	Rosalis Crab Company	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
February 01, 2000	Gifford Memorial Hospital	New England District Office	Mammography Standards	N/A *
February 01, 2000	ProSun Tanning Industries Inc	Florida District Office	Quality System Regulation/Tanning Beds	N/A *
February 01, 2000	Fred Schakel Dairy #2	Los Angeles District Office	Food/Cattle	N/A *
February 01, 2000	Washington County Memorial Hospital	Detroit District Office	Mammography Standards	N/A *
January 28, 2000	Williamson Charles H. M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
January 28, 2000	Edelweiss farms Inc.	New York District Office	Food/Dairy Cow	N/A *
January 27, 2000	Robert's American Gourmet	Center for Food Safety and Applied Nutrition	Food Labeling/Spirulina Spirals & Low Fat Fruity Booty	N/A *
January 27, 2000	Kamco Seafood Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
January 27, 2000	Kenai Custom Seafoods	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
January 26, 2000	Hudson Transit Lines Inc.	New York District Office	Insanitary Conditions/Backflow Prevention Device	N/A *
January 26, 2000	Hugh Chatham Memorial Hospital	Atlanta District Office	Mammography Standards	N/A *
January 26, 2000	Wilvarger General Hospital	Dallas District Office	Mammography Standards	N/A *
January 25, 2000	Weber Laboratories Inc.	Los Angeles District Office	CGMP/Finished Pharmaceuticals	N/A *
January 25, 2000	Puratos Corporation	New York District Office	Food Import/Not held for FDA examination	N/A *
January 25, 2000	Specialty Tint	Center for Devices and Radiological Health	Tinted Contact Lenses/Lack Premarketing Approval/Misbranded	N/A *
January 25, 2000	Fridley Medical Center	Minneapolis District Office	Mammography Standards	N/A *
January 24, 2000	Canyon Crest Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Nature's Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Sundance Farms	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Countyline Dairy #2	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	X-ray Preceptor	Dallas District Office	Mammography Standards	N/A *
January 24, 2000	Arroyo Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Rockhill Dairy L.L.C.	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Chaslee Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Roswell Livestock Auction Co.	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Tom Visser Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	NeuroControl Corp.	Cincinnati District Office	Quality System Regulation/NeuroControl Freehand System	N/A *
January 24, 2000	Pyramid Biological Corporation	Los Angeles District Office	Blood Products / Standard Operating Procedures	N/A *
January 24, 2000	Ahsley Valley Medical Center	Dallas District Office	Mammography Standards	N/A *
January 24, 2000	Faria Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Cottonwood Springs Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 24, 2000	Vaz Dairy	Denver District Office	Food/Dairy Cow	N/A *
January 21, 2000	Kirklin Clinic	Nashville District Office	Mammography Standards	N/A *
January 21, 2000	St. Vincent Women's Center at Lazarus-Castleton	Detroit District Office	Mammography Standards	N/A *
January 21, 2000	Calvin Scott & Company Inc.	Denver District Office	Prescription Non-prescription Drug Repackaging Relabeling/CGMP	N/A *
January 21, 2000	Tule River Dairy	San Francisco District Office	Food/Cattle	N/A *
January 20, 2000	Entringer Bakeries Inc.	New Orleans District Office	Insanitary Conditions	N/A *
January 20, 2000	Phillips Medical Systems No.Amerca	New England District Office	X-ray CAT System/Misbranded	N/A *
January 19, 2000	UHHS Bedford Medical Center	Cincinnati District Office	Mammography Standards	N/A *
January 19, 2000	Jefferson Hospital	Atlanta District Office	Mammography Standards	N/A *
January 19, 2000	Kosma-Kare Canada Inc.	Center for Devices and Radiological Health	Quality System Regulation/Medical Adhesive Bandages/Adulterated	N/A *
January 19, 2000	Medi-Royale Pastex Inc	Center for Devices and Radiological Health	Quality System Regulation/Medical Adhesive Bandages	N/A *
January 19, 2000	CryoGen Inc.	Center for Devices and Radiological Health	First Option Uterine Cryoblation Therapy/Lacks Premarket Approval/Misbranded	N/A *
January 14, 2000	Chilean Fish Corporation	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
January 14, 2000	Mc6 Cattle Feeders Inc.	Dallas District Office	Food/Cattle	N/A *
January 14, 2000	McFarling Foods Inc.	Detroit District Office	Seafood Processing Regulations/HACCP	N/A *
January 14, 2000	Gretna Drug Company Inc.	Baltimore District Office	Medical Gases / CGMP	N/A *

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