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
February 05, 2001	Lowell Products Development	Center for Devices and Radiological Health	Radiological Health/Records & Report/Performance Standards	N/A *
February 05, 2001	Kona Seafood Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
February 02, 2001	River Oaks East - Woman's Pavilion	New Orleans District Office	Mammography Standards	N/A *
February 02, 2001	Phelps County Regional Medical Center	Dallas District Office	Mammography Standards	N/A *
February 02, 2001	South Shore Breast Evaluation Center	New England District Office	Mammography Standards	N/A *
February 02, 2001	Family Medical Center	Atlanta District Office	Mammography Standards	N/A *
February 01, 2001	D&K Farm	New England District Office	Food/Cattle/Adulterated	N/A *
February 01, 2001	Respiratory Services Inc.	Denver District Office	Medical Oxygen/Adulterated	N/A *
February 01, 2001	Alaska Fresh Seafoods Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
February 01, 2001	T & G Sales	Dallas District Office	Imported Avocado Pulp/Not Held for Inspection	N/A *
February 01, 2001	Electrical Medical Systems Incorporated	Center for Devices and Radiological Health	TENS device & EMS unit/Adulterated/Lacks PMA/Misbranded/Not Substantially Equivalent	N/A *
February 01, 2001	Brooks Lawrence C. DVM	New England District Office	New Animal Drug/Illegal Drug Residue/Adulterated	N/A *
January 31, 2001	Medical College Of Pennsylvania Hospital	Philadelphia District Office	Mammography Standards	N/A *
January 31, 2001	Horizon Dairy	New York District Office	Food/Cattle/Adulterated	N/A *
January 31, 2001	Delray Medical Center	Florida District Office	Mammography Standards	N/A *
January 31, 2001	B & M Fish Co. LLC	New England District Office	Seafood Processing Regulations/HACCP	N/A *
January 30, 2001	Voyager Medical Corporation	Center for Devices and Radiological Health	Lacks Application for Premarket Approval/Misbranded/Not Substantially Equivalent/Adulterated	N/A *
January 30, 2001	St. Bernards Screening Mammography Center	Dallas District Office	Mammography Standards	N/A *
January 30, 2001	Dutch Farms	Chicago District Office	Insanitary Conditions/Food-Storage Warehouse/Adulterated	N/A *
January 30, 2001	Long's Peak Dairy	Denver District Office	Illegal Drug Residues/Adulterated	N/A *
January 29, 2001	Elmont Open MRI	New York District Office	Mammography Standards	N/A *
January 29, 2001	MSN Imaging Center	Chicago District Office	Mammography Standards	N/A *
January 29, 2001	Collins Fish & Seafood Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
January 29, 2001	Cracovia Company LLC	New England District Office	Seafood Processing Regulations/HACCP	N/A *
January 29, 2001	Brit Mart	Florida District Office	Food Products Not Held for Inspection	N/A *
January 29, 2001	Interstate Blood Bank	Minneapolis District Office	Current Good Manufacturing Practices for Blood and Blood Components	N/A *
January 28, 2001	Alaska Bounty Seafood & Smokery	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
January 26, 2001	Cooper County Memorial Hospital	Dallas District Office	Mammography Standards	N/A *
January 26, 2001	Alder Springs Smoked Salmon Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
January 26, 2001	Ainger Farm	Chicago District Office	Food/Cattle/Adulterated	N/A *
January 26, 2001	Gregg Jeffers Farm	Chicago District Office	Food/Cattle/Adulterated	N/A *
January 26, 2001	Columbia Medical Center West	Dallas District Office	Mammography Standards	N/A *
January 25, 2001	Jacobson Resonance Enterprises Inc.	Center for Devices and Radiological Health	Sponsor/Monitor/Contract Research Organization	N/A *
January 25, 2001	South Texas Mammography-Mobile	Dallas District Office	Mammography Standards	N/A *
January 25, 2001	St. Charles Hospital & Rehabilitation Center	New York District Office	Mammography Standards	N/A *
January 25, 2001	Premier Nutrition	Center for Food Safety and Applied Nutrition	Sports Bar/Misbrnaded/Food Labeling	N/A *
January 25, 2001	Roger Masselink Dairy	Detroit District Office	Food/Cattle/Adulterated	N/A *
January 25, 2001	CMED Inc.	Denver District Office	Uterine Balloon Therapy System/QS/GMP for Medical Devices Regulation/Adulterated	N/A *
January 25, 2001	New York Community Hospital	New York District Office	Mammography Standards	N/A *
January 25, 2001	Michiganan Farms Ltd.	Detroit District Office	Food/Cattle/Adulterated	N/A *
January 25, 2001	Our Lady of Mercy Medical Center	New York District Office	Mammography Standards	N/A *
January 24, 2001	Kibun Foods (U.S.A.) Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
January 24, 2001	DSM N.V.	Atlanta District Office	Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated	N/A *
January 23, 2001	Allergy Laboratories of Ohio Inc.	Center for Biologics Evaluation and Research	GMP for Finished Pharmaceuticals/Biologicals/Reporting of Errors/Changes to Approved Application	N/A *
January 23, 2001	Madison Medical Affiliates Inc.	Minneapolis District Office	Mammography Standards	N/A *
January 23, 2001	Stock Island Lobster Co.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
January 23, 2001	Dixie Health Inc.	Atlanta District Office	New Drug/Labeling/Misbranded	N/A *
January 22, 2001	Marathon Cheese Corp.	Minneapolis District Office	Substituting Labeling and Selling Muenster Cheese as Monterey Jack or Mozzarella Cheese	N/A *
January 22, 2001	Aventis Behring L.L.C.	Center for Biologics Evaluation and Research	Good Manufactuting Practices for Finished Pharmaceuticals/Biologicals Physical Establishment Etc.	N/A *
January 19, 2001	Allison Breast Center at Monument Radiology	Baltimore District Office	Mammography Standards	N/A *

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