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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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 06, 1998 Biotronix 2000 Inc. Center for Devices and Radiological Health Devices/NeedleSafe N/A *
August 06, 1998 Giant Gun Electrical Optical Co. Center for Devices and Radiological Health Devices/Laser Systems N/A *
August 06, 1998 Oreck Corporation Center for Devices and Radiological Health Devices/Hypo-Allergenic Air Machine N/A *
August 06, 1998 Health Science Laboratories and Services Inc. New Jersey District Office Drug Products/GMP N/A *
August 06, 1998 Willows General Store Inc. New England District Office Labeling/New Drug Application N/A *
August 06, 1998 Transverse Industries Co. Ltd. Center for Devices and Radiological Health Laser Products / Noncompliance N/A *
August 05, 1998 Bromenn Healthcare Chicago District Office Medical Oxygen N/A *
August 05, 1998 Herbal Pop Enterprises Inc. Kansas City District Office New Drug Application [NDA] N/A *
August 04, 1998 Summit Insudtries Inc. Atlanta District Office Drug Products / CGMP N/A *
August 04, 1998 Mincing Trading Corporation New York District Office Food/Seasoning N/A *
August 04, 1998 Miskin Barry M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
August 04, 1998 Perez Francisco New York District Office Food / Cheese Products N/A *
August 04, 1998 Community Surgical Supply New Jersey District Office Compressed Oxygen N/A *
August 03, 1998 Mirage Spas and Tanning Salon Dallas District Office Sunlamp Products N/A *
July 30, 1998 St. Elizabeth Hospital Seattle District Office Mammography Standards N/A *
July 30, 1998 Phoenix Cosmetics Laboratories Inc. New York District Office Drug Products/Labeling N/A *
July 29, 1998 Ivy Laboratories Inc. Kansas City District Office Veterinary Drugs N/A *
July 28, 1998 Alpha Therapeutic Corporation Seattle District Office Blood Products / Standard Operating Procedures N/A *
July 28, 1998 Murray Shore Pharmacy Center for Drug Evaluation and Research Prescription Drug Products N/A *
July 27, 1998 Atlantic Cape Fisheries Inc. New Jersey District Office Seafood Processing Regulations N/A *



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ICECI Warning Letters

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Food and Drug Administration

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