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
July 30, 2001	B-G Lobster & Shrimp Corporation	New York District Office	Seafood HACCP	N/A *
July 27, 2001	Reliv International, Inc.	Kansas City District Office	Food Labeling/Dietary Supplements/Misbranded	N/A *
July 27, 2001	Professional Compounding Centers of America, Inc.	Dallas District Office	Lacks IND or Approved NDA/Misbranded/Adulterated	N/A *
July 27, 2001	Southwest Airlines, Inc.	Dallas District Office	Interstate Conveyance Sanitation Regulations	N/A *
July 27, 2001	Engelberg, Jerry, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 27, 2001	Kaken Pharmaceuticals Co., Ltd.	Center for Drug Evaluation and Research	Active Pharmaceutical Ingredient/Adulterated	N/A *
July 26, 2001	TCPI, Inc.	Florida District Office	In Vitro Diagnostic Tests/Quality System Regulation/Adulterated	N/A *
July 26, 2001	Holiday Seafood, Inc.	Florida District Office	Seafood HACCP	N/A *
July 26, 2001	Global Laser Vision	Center for Devices and Radiological Health	Device/Adulterated	N/A *
July 26, 2001	R-Kane Prodcuts, Inc.	New Jersey District Office	Food Labeling Requirements/Misbranded	N/A *
July 26, 2001	Airway Outpatient Center	Los Angeles District Office	Mammography Quality Standards	N/A *
July 25, 2001	Pasco Imaging & Open MRI Center	Florida District Office	Mammography Quality Standards	N/A *
July 25, 2001	Black Tiger Co. Inc.	New Jersey District Office	Seafood HACCP	N/A *
July 25, 2001	Pacific Network, Inc.	San Francisco District Office	Seafood HACCP/GMP Requirements for Foods/Tuna & Marlin/Adulterated	N/A *
July 25, 2001	Haifa Smoked Fish, Inc.	New York District Office	Seafood HACCP	N/A *
July 25, 2001	The Cooper Companies, Inc.	New England District Office	Medical Device Reporting Regulation/Misbranded	N/A *
July 25, 2001	Women's Diagnostic Clinic, Inc.	Cincinnati District Office	Mammography Quality Standards	N/A *
July 25, 2001	Manuel Lima Dairy	San Francisco District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
July 25, 2001	Amherst Radiology	New York District Office	Mammography Quality Standards	N/A *
July 25, 2001	Parmalat/Farmland Dairies	New Jersey District Office	Westbrae Natural Rice Beverage/Labeling/Misbranded	N/A *
July 25, 2001	Brown, Candace S., Pharm.D, FNP	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
July 24, 2001	Cajun Gold Catfish Processors, Inc.	New Orleans District Office	Seafood HACCP/Catfish Products/Adulterated	N/A *
July 24, 2001	Bayer Corporation	Center for Biologics Evaluation and Research	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
July 24, 2001	Ovlmmune	Center for Biologics Evaluation and Research	Sponsor/Monitor/Contract Research Organization	N/A *
July 23, 2001	McPherson Hospital	Detroit District Office	Mammography Quality Standards	N/A *
July 20, 2001	Feel Good For Life, Inc.	Denver District Office	Magnetic Therapy Devices/Adulterated/Misbranded	N/A *
July 20, 2001	Cortland Memorial Hospital	New York District Office	Mammography Quality Standards	N/A *
July 20, 2001	Farnam Companies, Inc.	Kansas City District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
July 20, 2001	Engler Engineering Corporation	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
July 20, 2001	VF Works, Inc.	Florida District Office	Quality System Regulation/Videoflouroscopes/Adulterated	N/A *
July 20, 2001	Sharma, Ashok K., M.D.	Baltimore District Office	Mammography Quality Standards	N/A *
July 19, 2001	Titan Scan Technologies	Denver District Office	Quality System Regulation/Adulterated	N/A *
July 19, 2001	Progeny, Inc.	Chicago District Office	Medical Device Corrections and Removals/Misbranded	N/A *
July 19, 2001	B & J Seafood L.L.C.	Atlanta District Office	Seafood HACCP/Fresh Crabmeat	N/A *
July 19, 2001	Norquest Seafoods, Inc.	Seattle District Office	Seafood HACCP/Cooked Shrimp & Crab	N/A *
July 19, 2001	Armand's Seafood	New Orleans District Office	Seafood HACCP	N/A *
July 19, 2001	Sutter Lakeside Hospital	San Francisco District Office	Mammography Quality Standards	N/A *
July 18, 2001	St. Joseph Health Center	Dallas District Office	Mammography Quality Standards	N/A *
July 18, 2001	SeQual Technologies, Inc.	Los Angeles District Office	Quality System Regulation/Portable Oxygen concentrators/Adulterated	N/A *
July 18, 2001	Doctors Hospital Springfield	Dallas District Office	Mammography Quality Standards	N/A *
July 18, 2001	United Fish Distributors, Inc.	Detroit District Office	Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
July 18, 2001	Maxum Diagnostic Center	Dallas District Office	Mammography Quality Standards	N/A *
July 18, 2001	Swope Parkway Health Center	Dallas District Office	Mammography Quality Standards	N/A *
July 18, 2001	Baptist St. Anthony's Hospital	Dallas District Office	Mammography Quality Standards	N/A *
July 17, 2001	Nejatheim, Masood M.D.	New York District Office	Mammography Quality Standards	N/A *
July 17, 2001	Centura Health-Summit Medical Center	Dallas District Office	Mammography Quality Standards	N/A *
July 17, 2001	East Texas Radiological Consultants	Dallas District Office	Mammography Quality Standards	N/A *
July 17, 2001	Breast Center of Texoma	Dallas District Office	Mammography Quality Standards	N/A *
July 16, 2001	Georgetown Seafood Co., Inc.	Atlanta District Office	Seafood HACCP	N/A *
July 16, 2001	Santoriello, Kathy A., M.D. , P.A.	Atlanta District Office	Mammography Quality Standards	N/A *

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