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U.S. Department of Health and Human Services

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1998 Warning Letters

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Tobacco Retailer Warning Letters

 

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 11, 1998 Stoltzfus Samuel A. [ARCHIVED] Philadelphia District Office Food/Cattle N/A *
August 11, 1998 Aurora Health Care Inc. [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
August 11, 1998 Alcon Laboratories Inc. [ARCHIVED] Baltimore District Office Intraocular Optical Lenses N/A *
August 11, 1998 Yow Tech Electronic Co. Ltd. [ARCHIVED] Center for Devices and Radiological Health Laser Products / Noncompliance N/A *
August 11, 1998 Chiron Corporation [ARCHIVED] Center for Biologics Evaluation and Research Medical Devices / [QS] Quality Systems Regulations N/A *
August 11, 1998 Caleb Laboratories Inc. [ARCHIVED] Minneapolis District Office CGMP/Finished Pharmaceuticals N/A *
August 11, 1998 Doo Rae Trading Corporation [ARCHIVED] Los Angeles District Office Food/Fishcake Product Labeling N/A *
August 11, 1998 Coloplast Corporation [ARCHIVED] Minneapolis District Office Finished Pharmaceuticals N/A *
August 10, 1998 Rocap Div. of Sabratek [ARCHIVED] Florida District Office Medical Devices / [QS] Quality Systems Regulations N/A *
August 10, 1998 Welsh Farms Ice Cream [ARCHIVED] New Jersey District Office Dairy Products / CGMP N/A *
August 10, 1998 St. Thomas More Hospital [ARCHIVED] Denver District Office Blood Products / Standard Operating Procedures N/A *
August 07, 1998 Unlimited Futures Inc. [ARCHIVED] Minneapolis District Office Drug Products N/A *
August 07, 1998 Powertron Medical Devices Inc. [ARCHIVED] Florida District Office Medical Devices / [QS] Quality Systems Regulations N/A *
August 07, 1998 VF Works Inc. [ARCHIVED] Florida District Office Medical Devices / CGMP N/A *
August 07, 1998 Battery Marketing Associates [dba] Sunn Battery Company [ARCHIVED] Florida District Office Medical Devices / [QS] Quality Systems Regulations N/A *
August 07, 1998 Oakview Dairy [ARCHIVED] San Francisco District Office Food/Cattle N/A *
August 07, 1998 Mallinckrodt Inc. [ARCHIVED] Atlanta District Office Drug Products/GMP N/A *
August 06, 1998 Washington Heights Pharmacy Inc. [ARCHIVED] Baltimore District Office Liquid Oxygen / CGMP N/A *
August 06, 1998 Pray's Farmers Market [ARCHIVED] Buffalo District Office Food/Lemons and Bananas N/A *
August 06, 1998 Dentsply International Inc. [ARCHIVED] Chicago District Office Medical Devices N/A *



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ICECI Warning Letters

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