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



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ICECI Warning Letters

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