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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
June 22, 1998 Professional Dental Technologies Inc. (Pro-Dentec) Dallas District Office Drug Products N/A *
June 22, 1998 Acoma Medical Imaging Inc. Chicago District Office X-Ray Systems N/A *
June 22, 1998 Epitope Inc. Center for Biologics Evaluation and Research Quality System Regulation Violations / Office of Blood Research & Review N/A *
June 19, 1998 MWM LLC Chicago District Office Prescription Drugs N/A *
June 19, 1998 University Medical Center New Orleans District Office Blood Bank N/A *
June 19, 1998 Tri-Star Instruments Inc. Chicago District Office Medical Devices N/A *
June 19, 1998 Aubrey/Pilot Point Professional Products Dallas District Office Veterinary Drugs N/A *
June 18, 1998 Hereford Regional Medical Center Dallas District Office Mammography Standards N/A *
June 18, 1998 Gamma Biologicals Incorporated Center for Biologics Evaluation and Research Deviation from applicable Standard Operating Procedures N/A *
June 18, 1998 Ayurvedic Concepts Ltd. Dallas District Office Drug Products N/A *
June 18, 1998 Fan Shaing Electronics Co. Ltd. Center for Devices and Radiological Health Quality Control & Testing / Radiation Control N/A *
June 17, 1998 J. Bernard Seafood Processing Inc. New Orleans District Office Insanitary Conditions N/A *
June 17, 1998 Midstate Medical Inc. Baltimore District Office Compressed Oxygen N/A *
June 17, 1998 Kam Lam Trading Inc. San Francisco District Office Food / Mushrooms N/A *
June 17, 1998 Joe Gorzeman Dairy #2 Los Angeles District Office Food/Cattle N/A *
June 17, 1998 J. Strickland & Company Nashville District Office Drug Products N/A *
June 17, 1998 Interstate Blood Bank Inc. Nashville District Office Blood Products N/A *
June 17, 1998 Image Engineering Corporation Center for Devices and Radiological Health Laser Product Performance Standard N/A *
June 16, 1998 Merck & Company Inc. Philadelphia District Office Drug Products N/A *
June 16, 1998 Life Pulse LLC Kansas City District Office Blood Products N/A *



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ICECI Warning Letters

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