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 May 26, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 04, 2001	Prpctor & Gamble	San Juan District Office	CGMP for Finished Pharmaceuticals/Human Drug Manufacturing Facility/Adulterated	N/A *
May 04, 2001	Material Resources LLC	Chicago District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
May 04, 2001	Oriental Food Marketing Inc.	New England District Office	Seafood HACCP	N/A *
May 04, 2001	Golden International Import Export Corporation	Seattle District Office	Seafood HACCP	N/A *
May 04, 2001	Procter & Gamble	San Juan District Office	CGMP for Finished Pharmaceuticals/Human Drug Manufacturing Facility/Adulterated	N/A *
May 04, 2001	Puretone Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
May 03, 2001	Tyler Memorial Hospital	Philadelphia District Office	Mammography Quality Standards	N/A *
May 03, 2001	Permobil AB	Center for Devices and Radiological Health	Powered Wheelchair/Quality System Regulation	N/A *
May 03, 2001	HCA The Healthcare Company	Denver District Office	CGMP/Blood & Blood Components	N/A *
May 03, 2001	Lansdale Medical Group P.C.	Philadelphia District Office	Mammography Quality Standards	N/A *
May 02, 2001	Lourdes Medical Center	Seattle District Office	Mammography Quality Standards	N/A *
May 01, 2001	Dark Hollow Foods	Baltimore District Office	Good Manufacturing Practices for Acidified Foods/Adulterated	N/A *
May 01, 2001	DFW International Airport	Dallas District Office	Airline Support Facility/Interstate Conveyance Sanitation	N/A *
May 01, 2001	COATS Aloe International Inc.	Dallas District Office	CGMP for Finished Pharmaceuticals/Drug and Cosmetic Manufacturing Facility/Adulterated	N/A *
April 30, 2001	Lakeland Medical Associates	Dallas District Office	Mammography Quality Standards	N/A *
April 30, 2001	Larson's Dairy Inc.	Florida District Office	Drug Residues/Edible Tissues/Adulterated	N/A *
April 30, 2001	County Distributors Inc.	New England District Office	Seafood HACCP	N/A *
April 27, 2001	Group Health Cooperative-Eastside Hospital	Seattle District Office	Mammography Quality Standards	N/A *
April 27, 2001	Maruwa Skokai Guam Inc.	Los Angeles District Office	Seafood HACCP	N/A *
April 27, 2001	Johnson Donald R. M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
April 27, 2001	Wilson N. Jones Women's Imaging Center	Dallas District Office	Mammography Quality Standards	N/A *
April 27, 2001	Alaska Garden and Pet Supply Inc.	Seattle District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 27, 2001	Meiko Food Company	Los Angeles District Office	Seafood HACCP/CGMP/Misbranded	N/A *
April 26, 2001	Women's Center of Lexington	Atlanta District Office	Mammography Quality Standards	N/A *
April 26, 2001	Richardson Labs Inc.	Center for Food Safety and Applied Nutrition	Unapproved Food Additive/Unauthorized Nutrient Content Claim	N/A *
April 26, 2001	Rabun County Memorial Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
April 25, 2001	VEGA Grieshaber KG	Atlanta District Office	Device Lacks Marketing Clearance Approval/Adulterated/Misbranded	N/A *
April 25, 2001	Biological Technologies International Inc.	Center for Devices and Radiological Health	Lacks Premarket Notification/Adulterated/Misbranded	N/A *
April 25, 2001	Lime Creek Ag Services Inc.	Minneapolis District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 25, 2001	Colgate-Pamolive Company	New York District Office	NDA Fails To Bear Adequate Directions/Misbranded	N/A *
April 25, 2001	Janice's Kitchen	Baltimore District Office	Seafood HACCP/Deviled Crab Processing Facility	N/A *
April 25, 2001	Natural Health Consultants	Center for Devices and Radiological Health	Lacks Premarket Notification/Adulterated/Misbranded	N/A *
April 25, 2001	Lucky International Trading Inc.	Kansas City District Office	Food Storage Warehouse/Insanitary Conditions/Adulterated	N/A *
April 25, 2001	BioEclectic Research	Center for Devices and Radiological Health	Device /Lacks Marketing Clearance Approval/Adulterated/Misbranded	N/A *
April 25, 2001	Western Plains Medical Complex	Dallas District Office	Mammography Quality Standards	N/A *
April 25, 2001	LSG Sky Chefs Inc.	Dallas District Office	Airline Catering Facility/Insanitary Conditions	N/A *
April 24, 2001	Albermarle Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
April 24, 2001	Med-Pharmex Inc.	Los Angeles District Office	Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals	N/A *
April 24, 2001	Waldron Smokehouse Specialties Inc.	Seattle District Office	Seafood HACCP	N/A *
April 24, 2001	Marshall Regional Medical Center	Dallas District Office	Mammography Quality Standards	N/A *
April 23, 2001	HealthCrest	Center for Devices and Radiological Health	Fertility Awareness Kit-The Lens/Lacks Premarket Notification/Misbranded/Adulterated	N/A *
April 23, 2001	White County Hospital	New Orleans District Office	Mammography Quality Standards	N/A *
April 23, 2001	R & G Medical and Development Corporation	Center for Devices and Radiological Health	Self Pap/Lacks Premarket Notification/Adulterated/Misbranded	N/A *
April 23, 2001	Earl B. Olson Feed Mill	Minneapolis District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 20, 2001	Club Fitness	Dallas District Office	Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded	N/A *
April 20, 2001	Grafor Manufacturing Inc.	San Juan District Office	Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated	N/A *
April 20, 2001	St. Joseph's Imaging Associates	New York District Office	Mammography Quality Standards	N/A *
April 19, 2001	Fresh Island Fish Company Inc.	San Francisco District Office	Seafood HACCP/Histamine Forming Fish/Adulterated	N/A *
April 19, 2001	Accent Health Care	Chicago District Office	CGMP/Liquid Oxygen/Adulterated	N/A *
April 19, 2001	Green Turtle Cannery	Florida District Office	Low Acid Canned Food Regulation/Adulterated	N/A *

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