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
May 16, 2000	Quality Fruits Products Corp.	San Juan District Office	Food Product Manufacturing Facitity/Labeling	N/A *
May 15, 2000	Rifton Aviation Services	New York District Office	Control of Communicable Diseases and Interstate Conveyance Regulations Violations	N/A *
May 15, 2000	Ferolito Vultaggio & Sons Inc.	Center for Food Safety and Applied Nutrition	Arizona Rx Stress Relief Elixir/Misbranded/Labeling	N/A *
May 12, 2000	Whole Living Inc.	Denver District Office	Progesterone cream/New Drug/Labeling/Misbranded	N/A *
May 12, 2000	Wa Heng Dou Fu Soy Sauce Int Enterprises	San Francisco District Office	Insanitary Practices & Conditions	N/A *
May 12, 2000	Pacific Harvest Products Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
May 12, 2000	Zarda King Ltd.	Chicago District Office	Food Products Storage/Insanitary Conditions	N/A *
May 12, 2000	Sandwich Shoppe	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
May 11, 2000	Focus Imaging Group Inc.	Florida District Office	Diagnostic Ultrasound Equipment/Lacks Premarket Approval/Misbranded	N/A *
May 11, 2000	Euthenics International Inc.	Denver District Office	Trandermal Delivery System/New Drug	N/A *
May 11, 2000	International Imaging Electronics Inc.	Chicago District Office	Quality System Regulation/Medical Imaging Electronic Equipment	N/A *
May 10, 2000	Paragon Implant Company	Center for Devices and Radiological Health	Paragon Swiss Plus Implant System/Promotional Claims/Lacks Approved Pre-market Application	N/A *
May 10, 2000	Dean Health System Inc.	Minneapolis District Office	Mammography Standards	N/A *
May 10, 2000	Home Care Equipment Inc.	Baltimore District Office	Medical Gases / CGMP	N/A *
May 10, 2000	South Bend Packers Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
May 10, 2000	Hocking Valley Community Hospital	Cincinnati District Office	Mammography Standards	N/A *
May 09, 2000	Petersburg Medical Center	Seattle District Office	Mammography Standards	N/A *
May 09, 2000	Wheeler Seafoods Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
May 09, 2000	KV Pharmaceutical Company	Kansas City District Office	Drug Manufacturing Operations/CGMP deviations	N/A *
May 09, 2000	Interim Penn Memorial Hospital	Atlanta District Office	Mammography Standards	N/A *
May 09, 2000	Louisiana Substance Abuse Clinic Inc.	New Orleans District Office	Narcotic Treatment Standards Violations	N/A *
May 09, 2000	Posey Crab Company	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
May 08, 2000	Schering-Plough Laboratories	San Juan District Office	Human Veterinary Pharmaceutical Manufacturing Facility/CGMP/Finished Pharmaceuticals	N/A *
May 08, 2000	Newport Hospital and Clinic	Dallas District Office	Mammography Standards	N/A *
May 08, 2000	Valley National Gases Inc.	New Jersey District Office	Finished Pharmaceuticals/Oxygen Repackaging Facility/CGMP	N/A *
May 08, 2000	Vista Mundo Inc.	Florida District Office	St. Lucia Eye Drops/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded	N/A *
May 08, 2000	DBA Get Huge	Los Angeles District Office	Trican (tiratricol)/Unapproved New Drug Application/Misbranded/Not a Dietary Supplement	N/A *
May 08, 2000	Biosil Limited	Center for Devices and Radiological Health	Medical Devices Regulation/Saline Fill Mammary Implants	N/A *
May 08, 2000	MedGyn Products Inc.	Chicago District Office	Quality System Regulation/ Obstetrical & Gynecological Devices	N/A *
May 08, 2000	Gulf Go-Fers Incorporated	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
May 05, 2000	Chattanooga Diagnostic Imaging	Nashville District Office	Mammography Standards	N/A *
May 05, 2000	Enzymatic Therapy Inc.	Minneapolis District Office	Glucosamine Sulfate & Nasal Decongestant Products/Lacks Approved NDA/Misbranded/Labeling	N/A *
May 05, 2000	Taku Smokeries/Fisheries	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
May 05, 2000	South Jersey Radiology Associates P.A.	New Jersey District Office	Mammography Standards	N/A *
May 05, 2000	Lee Memorial Hospital Blood Band	Florida District Office	Blood Band & Laboratory/CGMP/Blood & Blood Component Regulations	N/A *
May 05, 2000	Thames Pharmacal Co. Inc.	New York District Office	CGMP/Finished Pharmaceuticals	N/A *
May 04, 2000	Dhanraj	San Francisco District Office	Insanitary Conditions	N/A *
May 04, 2000	Mofel's Food International Corporation	Center for Food Safety and Applied Nutrition	Seafood Processing Regulations/HACCP	N/A *
May 04, 2000	Kershaw County Medical Center	Atlanta District Office	Mammography Standards	N/A *
May 03, 2000	Health Plus Medical Group	Dallas District Office	Mammography Standards	N/A *
May 03, 2000	Business Express Airlines	New York District Office	Interstate Conveyance Sanitation Regulation Deficiencies	N/A *
May 03, 2000	Golden Plains Community Hospital	Dallas District Office	Mammography Standards	N/A *
May 02, 2000	Nelson and Sons Inc.	Denver District Office	Medicated Feeds/CGMP	N/A *
May 02, 2000	Dhanraj	San Francisco District Office	Insanitary Conditions	N/A *
May 02, 2000	Rich Lou Farm	Philadelphia District Office	Food/Cattle	N/A *
May 01, 2000	Margaret Mary Community Hospital	Detroit District Office	Mammography Standards	N/A *
April 30, 2000	Tyler Donnie	Cincinnati District Office	Food/Cattle	N/A *
April 28, 2000	Reinauer Transportation Co.	New York District Office	Vessel Watering Points	N/A *
April 28, 2000	Albert Lea Medical Center	Minneapolis District Office	Mammography Standards	N/A *
April 28, 2000	Advanced Health CAre	Minneapolis District Office	Mammography Standards	N/A *

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