1999 Warning Letters

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Warning Letters for 1999

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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
October 22, 1999	Matrix Biokinetics Inc.	San Francisco District Office	Quality System Requirement	N/A *
October 22, 1999	Minnesota Valley Health Center	Minneapolis District Office	Mammography Standards	N/A *
October 21, 1999	Dave handrigan Seafoods	New England District Office	Seafood Processing Regulations/HACCP	N/A *
October 21, 1999	Medeva Pharma Ltd	Center for Biologics Evaluation and Research	Diagnostic Standards/Laboratory Practices	N/A *
October 20, 1999	DeLuca James M.D.	New York District Office	Mammography Standards	N/A *
October 20, 1999	Ginesis Natural Products Inc.	New Orleans District Office	Drug Products/Cosmetic Claims	N/A *
October 20, 1999	Servisios Medicos Internacionales de Mexico/Mexico	Center for Drug Evaluation and Research	Marketing without NDA/Misbranding	N/A *
October 20, 1999	Servisios Medicos Internacionales de Mexico/California	Center for Drug Evaluation and Research	Marketing without NDA/Misbranding	N/A *
October 20, 1999	Noah Weg & Associates	New York District Office	Mammography Standards	N/A *
October 19, 1999	Somerset Medical Center	New Jersey District Office	Blood & Blood Components	N/A *
October 19, 1999	Chemrite Industries Inc.	Minneapolis District Office	Drug Manufacturing Facility(OTC)/cGMP	N/A *
October 19, 1999	Garden & Valley Seafood Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
October 19, 1999	Refreshqueria Jerry	San Juan District Office	Labeling/Juice Beverage Products	N/A *
October 19, 1999	Massena Memorial Hospital	New York District Office	Mammography Standards	N/A *
October 19, 1999	Rhone-Poulenc Rorer	San Juan District Office	CGMP for Deviations/Adulterated	N/A *
October 18, 1999	Lakeshore Clinic Totem Lake	Seattle District Office	Mammography Standards	N/A *
October 18, 1999	Chianti Cheese Co.	New Jersey District Office	Misbranded/Cheeses	N/A *
October 18, 1999	Clinical Pharmacology Associates	Center for Drug Evaluation and Research	Bioequivalence	N/A *
October 18, 1999	Community Blood Council of New Jersey Inc.	New Jersey District Office	Blood & Blood Components	N/A *
October 15, 1999	Nocona General Hospital	Dallas District Office	Mammography Standards	N/A *
October 15, 1999	Mercy Diagnostics	Cincinnati District Office	Mammography Standards	N/A *
October 15, 1999	Farmo Corporation	San Francisco District Office	Labeling/Cheese Processing Facility/Unsanitary Conditions	N/A *
October 15, 1999	Wyss Hansjoery J.	Denver District Office	Quality System regulation/Implantable Screws Nails Plates etc.	N/A *
October 15, 1999	Bronx Lebanon Hospital Center	New York District Office	Mammography Standards	N/A *
October 15, 1999	Wyoming County Community Hospital	New York District Office	Mammography Standards	N/A *
October 14, 1999	Vanguard Medical Concepts Inc.	Florida District Office	Quality System Regulation/Reprocessing Biopsy Forceps	N/A *
October 14, 1999	North Adams Regional Hospital	New England District Office	Mammography Standards	N/A *
October 14, 1999	Lahey Beverly	New England District Office	Mammography Standards	N/A *
October 14, 1999	Jones Clinic Physician Network L.L.C.	Detroit District Office	Mammography Standards	N/A *
October 14, 1999	Grand View Hospital	Detroit District Office	Mammography Standards	N/A *
October 13, 1999	Hillsborough Family Medical Center	Atlanta District Office	Mammography Standards	N/A *
October 13, 1999	Carolinas Hospital System - Kingstree	Atlanta District Office	Mammography Standards	N/A *
October 13, 1999	Summit Radiology	Seattle District Office	Mammography Standards	N/A *
October 13, 1999	University of Minnesota	Minneapolis District Office	Medicated Feeds/CGMP	N/A *
October 13, 1999	Breast Care Center Sedro-Woolley	Seattle District Office	Mammography Standards	N/A *
October 12, 1999	Icicle Seafoods Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
October 08, 1999	Xavier Cattle-Holsteins	San Francisco District Office	Food/Cattle	N/A *
October 08, 1999	Sunnyside Farms Inc.	New Jersey District Office	Food/Cattle	N/A *
October 08, 1999	Gideon 300 Club The	Atlanta District Office	Seafood Processing Regulations/HACCP	N/A *
October 08, 1999	North American Vaccine Inc.	Center for Biologics Evaluation and Research	Production process Controls/Failure to Report Changes to Application	N/A *
October 07, 1999	Tuls Cattle Co.	San Francisco District Office	Food/Cattle	N/A *
October 07, 1999	Valley Regional Medical Center	Dallas District Office	Mammography Standards	N/A *
October 07, 1999	United Diagnostic Center	Dallas District Office	Mammography Standards	N/A *
October 07, 1999	Breakwater Seafoods	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
October 07, 1999	LifeSouth Community Blood Service	Atlanta District Office	Blood & Blood Components	N/A *
October 07, 1999	Reel Food Service Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
October 07, 1999	Dairy Veterinary Services	San Francisco District Office	Extralabel Drug Use In Animals	N/A *
October 07, 1999	Williams Johnny R.	San Francisco District Office	Human Prescription Drugs Sale and Distribution for Veterinary Purposes	N/A *
October 07, 1999	Robert Van Grouw Dairy	San Francisco District Office	Food/Cattle	N/A *
October 07, 1999	Genesis Pharmaceutical Inc.	Detroit District Office	Subsidiary Firm/cGMP	N/A *

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