2000 Warning Letters

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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
March 29, 2000	Victory Seafood Processors Inc.	New Orleans District Office	Seafood Processing Regulations/HACCP	N/A *
March 29, 2000	Cohn Cal K. M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
March 29, 2000	Body Best Inc.	Florida District Office	HGH Support/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded	N/A *
March 28, 2000	Flying Food Group Inc.	New York District Office	Airline Catering Facility	N/A *
March 27, 2000	N.T.T. Seafood Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
March 27, 2000	Manjean Holsteins	San Francisco District Office	Food/Cattle	N/A *
March 24, 2000	High Point Regional Health System	Atlanta District Office	Mammography Standards	N/A *
March 24, 2000	Griffin Hospital	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
March 24, 2000	Cadell Dry Dock & Ship Repair Inc.	New York District Office	Vessel Watering Points	N/A *
March 24, 2000	Palmyra Medical Centers	Atlanta District Office	Mammography Standards	N/A *
March 24, 2000	United Metabolic Research Center	Atlanta District Office	Betadrene-SR/Lacks Approved New Drug Application	N/A *
March 24, 2000	Tony Sousa Dairy	San Francisco District Office	Food/Cattle	N/A *
March 23, 2000	Joe Andrade Family Dairy	San Francisco District Office	Food/Cattle	N/A *
March 23, 2000	Sparkling Springs Farm	Philadelphia District Office	Food/Cattle	N/A *
March 23, 2000	Medtronic Inc.	Center for Devices and Radiological Health	Activa Tremor Control System/Promotional Claims/Class III Device/Lacks Premarket Approval	N/A *
March 23, 2000	Demetriades Demetrios M.D. Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
March 23, 2000	Fisher and Thompson	Philadelphia District Office	Veterinary Prescription Drug/Illegal Purchase Holding & Sale	N/A *
March 23, 2000	Alex Seafood Company Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
March 23, 2000	Davis Hospital and Medical Center	Dallas District Office	Mammography Standards	N/A *
March 23, 2000	Astan Inc.	Nashville District Office	Nail Cure/Lacks Approvad New Drug Application (NDA)/GMP Regulations	N/A *
March 22, 2000	Fair Oaks Imaging Center	Baltimore District Office	Mammography Standards	N/A *
March 22, 2000	Nature's Way	Center for Food Safety and Applied Nutrition	Food Labeling/Prgnancy-6	N/A *
March 22, 2000	Bayou Land Seafood	New Orleans District Office	Seafood Processing Regulations/HACCP	N/A *
March 22, 2000	PEL Associates Inc.	New Jersey District Office	Good Manufacturing Practices Violation/Finished Pharmaceuticals	N/A *
March 21, 2000	St. Joseph's Hospital	Baltimore District Office	Mammography Standards	N/A *
March 21, 2000	Slenders Dairy	San Francisco District Office	Food/Cattle	N/A *
March 21, 2000	Nutrisoy International Inc.	Detroit District Office	Soy Products/Lack Approved New Drug Application	N/A *
March 21, 2000	Sybron Internation Corporation	Denver District Office	Quality System Regulations/Sterilants & Disinfectants	N/A *
March 21, 2000	Florida Crab Company	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
March 20, 2000	Women's Center of Lexington	Atlanta District Office	Mammography Standards	N/A *
March 17, 2000	Teco Diagnostics	San Francisco District Office	One Step Morphine Urine Dipstick Test/Undeclared Medical Device Import	N/A *
March 17, 2000	Orange Diagnostic and Mammography Center	Baltimore District Office	Mammography Standards	N/A *
March 17, 2000	Moses Ludington Hospital	New York District Office	Mammography Standards	N/A *
March 17, 2000	Donnivale Farm	New York District Office	Food/Cattle	N/A *
March 17, 2000	Mallinckrodt Inc.	Kansas City District Office	Good Manufacturing Practices Violation/Finished Pharmaceuticals	N/A *
March 17, 2000	Harold Brouwer Dairy	San Francisco District Office	Food/Cattle	N/A *
March 16, 2000	ALK-Abello Inc.	Center for Biologics Evaluation and Research	Allergenic Extracts/Good Manufacturing Practices/Biologicals Standards Products	N/A *
March 16, 2000	Air Products & Chemicals Inc.	San Juan District Office	Medical Oxygen / CGMP	N/A *
March 16, 2000	Shield Technology Inc.	Dallas District Office	Chimal/Starlee Skin Shields/Lack Approved New Drug Application	N/A *
March 16, 2000	St. Joseph's Hospital and Medical Center	New Jersey District Office	Blood & Blood Components	N/A *
March 15, 2000	United States Dredging Corp.	New York District Office	Backflow Prevention Device	N/A *
March 15, 2000	Peninsula Diagnostic Center	Los Angeles District Office	Mammography Standards	N/A *
March 15, 2000	California Breastcare Centers - Mobile	Los Angeles District Office	Mammography Standards	N/A *
March 15, 2000	Dynair Services Inc.	Baltimore District Office	Interstate Conveyance Sanitation Regulation Deficiencies	N/A *
March 15, 2000	Walsh Manufacturing Ltd. P. dba Walsh Medical Devices	Center for Devices and Radiological Health	Quality System Regulation/Crawford Lacrimal Intubation Sets	N/A *
March 15, 2000	El Proyecto Del Barrio Inc.	Los Angeles District Office	Mammography Standards	N/A *
March 15, 2000	Physician's Choice Medical LLC.	Denver District Office	Medical Oxygen	N/A *
March 15, 2000	American Airlines	Baltimore District Office	Interstate Conveyance Sanitation Regulation Deficiencies	N/A *
March 15, 2000	Air Tran	Baltimore District Office	Interstate Conveyance Sanitation Regulation Deficiencies	N/A *
March 15, 2000	Medtronic Physio-Control	Seattle District Office	Quality System Regulation/Lifepak 500 Automated External Defibrillator	N/A *

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