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
September 11, 2000	Gulf Seafood of Key West Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
September 11, 2000	New Vision Co-op	Minneapolis District Office	Current Good Manufacturing Practices for Medicated Feeds	N/A *
September 11, 2000	Vennstra Dairy	Seattle District Office	Food/Cattle	N/A *
September 11, 2000	Lovelace Health Systems Inc.	Denver District Office	GMP for Blood & Blood Products/Adulterated	N/A *
September 08, 2000	Mercy Medical Center	Kansas City District Office	Medical Gas Transfilling Operation/Liquid Oxygen	N/A *
September 08, 2000	Mark II Enterprises	Cincinnati District Office	Medical Oxygen / CGMP	N/A *
September 08, 2000	Ameri-Pac Inc.	Kansas City District Office	Good Manufacturing Practice for Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility	N/A *
September 08, 2000	Harbor Docks Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
September 07, 2000	Cassidy's Seafood Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
September 07, 2000	Rainier Sprouts	Baltimore District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
September 06, 2000	Cape Atlantic Medical Inc.	New Jersey District Office	Medical Oxygen / CGMP	N/A *
September 06, 2000	BCA Internaional Inc.	Florida District Office	Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation	N/A *
September 06, 2000	New Pacific Inc.	Center for Devices and Radiological Health	Laser Product Performance Standards/Laser Light Show/Electronic Product Radiation Control	N/A *
September 06, 2000	Woman's Clinic	New Orleans District Office	Mammography Standards	N/A *
September 06, 2000	International Diagnostic & Medical Supply Corporation	Florida District Office	Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation	N/A *
September 06, 2000	Jerome Stevens Pharmaceuticals Inc.	New York District Office	Digoxin Tablets/Good Manufacturing Practices for Finished Pharmaceuticals	N/A *
September 05, 2000	Davis Dairy Farm	New England District Office	Food/Dairy Cow	N/A *
September 05, 2000	Bolivar General Hospital	New Orleans District Office	Mammography Standards	N/A *
September 05, 2000	Shands Jacksonville Medical Center	Florida District Office	Mammography Standards	N/A *
September 05, 2000	Jonlly Fruits, Inc.	San Juan District Office	Labeling/Adulterated/Misbranded	N/A *
September 05, 2000	Imaging Centers of Anaheim / Tan Tran M.D. Inc.	Los Angeles District Office	Mammography Standards	N/A *
September 05, 2000	San Gennaro Foods Inc.	Seattle District Office	Polenta/Production Processing Controls Acidified Foods etc.	N/A *
September 01, 2000	Diagnostic Medical Group of Southern California	Los Angeles District Office	Mammography Standards	N/A *
September 01, 2000	DeLonghi S.p.A	Center for Devices and Radiological Health	Federal Performance Standard for Microwave Ovens	N/A *
September 01, 2000	Slim Center	Florida District Office	Body Gel/Lacks "May Proceed Notice" or "Release Notice"	N/A *
September 01, 2000	Viking Village Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
August 31, 2000	Pear Garden Produce	Los Angeles District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 31, 2000	Consolidated Nutrition L.C.	San Juan District Office	Medicated Feeds	N/A *
August 31, 2000	Orange Bean Sprouts	Los Angeles District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 31, 2000	Monarch Seafoods Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
August 31, 2000	Nobel Biocare AB	Center for Devices and Radiological Health	Quality System Regulation/Sterile Dental Implants & Dental Surgical Instruments	N/A *
August 31, 2000	California Day-Fresh Foods Inc.	Los Angeles District Office	Unpasteurized Orange Juice/Labeling/Misbranded/Salmonella Contamination	N/A *
August 31, 2000	Calco Bean Sprouts Inc.	Los Angeles District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 30, 2000	St. James Mercy Hospital	New York District Office	Mammography Standards	N/A *
August 30, 2000	Paradigm Medical Industries Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
August 30, 2000	Thomasville Infirmary	New Orleans District Office	Mammography Standards	N/A *
August 30, 2000	Great Plains Seafood Inc.	Kansas City District Office	Seafood Processing Regulations/HACCP	N/A *
August 30, 2000	Magnetic Resonance of New Jersey	New Jersey District Office	Mammography Standards	N/A *
August 30, 2000	Betco Corporation Ltd.	Cincinnati District Office	OTC Drug Products/GMP	N/A *
August 30, 2000	Cooper Health System	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
August 30, 2000	Appalachina Medical Equipment Co. Inc.	Nashville District Office	Medical Oxygen / CGMP	N/A *
August 29, 2000	Princess Lifestyles	Los Angeles District Office	Sanalyn/Lacks Approved New Drug Application	N/A *
August 29, 2000	Rodriguez Inc.	Los Angeles District Office	Seafood Processing Regulations/HACCP	N/A *
August 29, 2000	Ameripec Inc.	Los Angeles District Office	Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food	N/A *
August 29, 2000	Medical Center Home Health Care Services Inc.	Florida District Office	Medical Oxygen / CGMP	N/A *
August 29, 2000	Christus St. Patrick Hoospital	Center for Biologics Evaluation and Research	IRB (Institutional Review Board)	N/A *
August 29, 2000	MD International Inc.	Florida District Office	Manometers & Stethoscopes/Lacks "May Proceed Notice" or "Release Notice"	N/A *
August 29, 2000	Dairymen's Division Land O'Lakes Dairy Foods	San Francisco District Office	Cheese & Milk Products/Manufactured from Raw Milk Containing Penicillin & Residue	N/A *
August 29, 2000	Rock Landing Seafood	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
August 29, 2000	North Cascade Family Physicians	Seattle District Office	Mammography Standards	N/A *

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