2001 Warning Letters

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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
October 29, 2001	Slacks, Inc.	Minneapolis District Office	Food Labeling/Misbranded	N/A *
October 29, 2001	Wilkinson Medical Clinics, S.C.	Minneapolis District Office	Mammography Quality Standards	N/A *
October 29, 2001	Texoma Medical Center	Dallas District Office	Mammography Quality Standards	N/A *
October 29, 2001	Bunnel, Inc	Denver District Office	Ventilators for Neonatal Use/Quality System/GMP for Medical Devices Regulation/Adulterated	N/A *
October 29, 2001	Trans Caribbean Dairy Corporation	San Juan District Office	Current Good Manufacturing Practice in Manufacturing, Packing, or Holding/Adulterated	N/A *
October 29, 2001	Medical Device Technologies, Inc.	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
October 26, 2001	French Delices, Inc.	Los Angeles District Office	Seafood HACCP	N/A *
October 26, 2001	Manatee Foods Inc DBA Manatee Sprout Company	Florida District Office	Insanitary Conditions/Adulterated	N/A *
October 26, 2001	Institute of Integrative Health	New Orleans District Office	New Drug/False Misleading/Labeling/Misbranded	N/A *
October 26, 2001	CC's Catering	Florida District Office	Seafood HACCP/Insanitary Conditions	N/A *
October 25, 2001	Enzyme Development Corporation	Philadelphia District Office	Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated	N/A *
October 25, 2001	ADAC Laboratories	San Francisco District Office	CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded	N/A *
October 24, 2001	Haag & Sons Seafood	Atlanta District Office	Seafood HACCP	N/A *
October 24, 2001	Open MRI of Inland Valley	Los Angeles District Office	Mammography Quality Standards	N/A *
October 24, 2001	Seafood Supplies	San Francisco District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
October 24, 2001	Dixon Feeds, Inc.	Seattle District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
October 24, 2001	Pope Dairy Enterprises	Minneapolis District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
October 24, 2001	Schwartz Appetizing, Inc.	New York District Office	Seafood HACCP	N/A *
October 24, 2001	Southwest Airlines	New York District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
October 24, 2001	Central American Produce	Florida District Office	Import/Not Held Intact	N/A *
October 24, 2001	Atlantic Cape Fisheries, Inc.	New Jersey District Office	Seafood HACCP	N/A *
October 23, 2001	Breast Care Center Sedro-Woolley	Seattle District Office	Mammography Quality Standards	N/A *
October 23, 2001	Purac America, Inc.	Buffalo District Office	Entry/Lacks "May Proceed" or "Release Notice"	N/A *
October 22, 2001	Concho Dairy Consulting	Minneapolis District Office	Illegal Drug Residue	N/A *
October 22, 2001	Natural Source, Inc.	San Juan District Office	CGMP in Mfg, Packing, or Holding Human Food/Processing & Bottling of Bottled Drinking Water	N/A *
October 22, 2001	Crown Mountain Natural Water, Inc.	San Juan District Office	CGMP in Mfg, Packing, or Holding Human Food/Processing & Bottling of Bottled Drinking Water	N/A *
October 19, 2001	Hilo Fish Company, Inc.	San Francisco District Office	Good Manufacturing Practice Regulations for Foods/Seafood HACCP	N/A *
October 19, 2001	Mary Immaculate Hospital	Baltimore District Office	Mammography Quality Standards	N/A *
October 19, 2001	Marin Breast Health Center	San Francisco District Office	Mammography Quality Standards	N/A *
October 19, 2001	Pimpy's Water Delivery	San Juan District Office	CGMP in Mfg, Packing, or Holding Human Food/Processing & Bottling of Bottled Drinking Water	N/A *
October 19, 2001	Valley General Hospital	Seattle District Office	Mammography Quality Standards	N/A *
October 19, 2001	Midwest Medical Holdings, LLC	Minneapolis District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 18, 2001	Romanucci Enterprises, Inc.	Chicago District Office	Insanitary Conditions/Adulterated	N/A *
October 18, 2001	Capital Fleet, Inc.	New Orleans District Office	Interstate Conveyance Sanitation Regulations	N/A *
October 18, 2001	Anthony Dinitto	Buffalo District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
October 18, 2001	Borgess at Woodbridge Hills	Detroit District Office	Mammography Quality Standards	N/A *
October 18, 2001	Franco Fish Products, Inc.	Seattle District Office	Seafood HACCP	N/A *
October 18, 2001	Wells Johnson Company	Los Angeles District Office	Quality System Regulation	N/A *
October 18, 2001	Surgical Instruments Service & Savings, Inc.	Atlanta District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
October 17, 2001	H & M Seafood	New Orleans District Office	Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP	N/A *
October 17, 2001	Kham Seafood Company	New Orleans District Office	Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP	N/A *
October 17, 2001	Sorenson Development, Inc.	Denver District Office	Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
October 17, 2001	Mississippi Food Service, Inc.	New Orleans District Office	Seafood HACCP	N/A *
October 17, 2001	Pet Magic, Inc.	Detroit District Office	Pig Ears Dog Treats/Lacks "May Proceed" or "Release Notice"	N/A *
October 17, 2001	Healthcare Partners Medical Group	Los Angeles District Office	Mammography Quality Standards	N/A *
October 17, 2001	Person & Covey	Los Angeles District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 16, 2001	E.M. Parker	Center for Devices and Radiological Health	Performance Standard for Diagnostic X-ray Equipment	N/A *
October 16, 2001	Omni Nutraceuticals, Inc.	Center for Drug Evaluation and Research	Labeling/Unapproved New Drug/Misbranded	N/A *
October 16, 2001	Ramco Laboratories, Inc.	Dallas District Office	CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded	N/A *
October 16, 2001	B.F. Ascher & Company, Inc.	Center for Drug Evaluation and Research	Labeling/Unapproved New Drug/Misbranded	N/A *

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