1998 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 1998

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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 21, 1998	Spiess Design Inc.	Chicago District Office	Devices/Endoscopes and Bipolar Forceps	N/A *
September 21, 1998	Innomedica Inc.	Minneapolis District Office	Medical Device Reporting	N/A *
September 21, 1998	Subacute Medical Care Inc.	New England District Office	Medical Oxygen	N/A *
September 21, 1998	Brandon Regional Hospital	Florida District Office	Mammography Standards	N/A *
September 21, 1998	Geneva Laboratories Incorporated	Minneapolis District Office	Deviation from Good Manufacturing Practice	N/A *
September 18, 1998	BioWhittaker Inc.	Center for Biologics Evaluation and Research	CGMP Deviations	N/A *
September 17, 1998	LOKKI Lasers Medicaux S.A.	Center for Devices and Radiological Health	Dental Lasers / Quality System Regulations	N/A *
September 17, 1998	Alanric Food Distributors Inc.	New Jersey District Office	Labeling/Food Products	N/A *
September 17, 1998	DeBos Dairy	Los Angeles District Office	Cattle / Food	N/A *
September 17, 1998	J and L Dairy	San Francisco District Office	Cattle / Food	N/A *
September 17, 1998	El Monte Dairy	San Francisco District Office	Cattle / Food	N/A *
September 17, 1998	Synthelabo Biomedical S.A. / Centre D'Affairs LaBoursidiere	Center for Devices and Radiological Health	Medical Devices / CGMP	N/A *
September 16, 1998	Obstetrics & Gynecology Associates P.A.	Florida District Office	Mammography Standards	N/A *
September 16, 1998	Self-Health Systems	Kansas City District Office	Devices/Glasses	N/A *
September 15, 1998	Body Systems Technology Inc.	Florida District Office	Drug Products/Labeling	N/A *
September 14, 1998	Gendron Inc.	Cincinnati District Office	Devices/Quality System Regulation	N/A *
September 14, 1998	Astra USA	New England District Office	Drug Product/New Drug Application	N/A *
September 11, 1998	Louisiana Royal Seafood Inc.	New Orleans District Office	Insanitary Conditions	N/A *
September 11, 1998	Hargenrader Farms	Philadelphia District Office	Cattle / Food	N/A *
September 11, 1998	Power Source Distributors Inc.	Nashville District Office	Drug Products/Labeling	N/A *

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