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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
July 17, 1998 Ravelco Inc. Florida District Office Labeling N/A *
July 16, 1998 Boehringer Mannheim Corp. San Francisco District Office Medical Devices N/A *
July 16, 1998 Animal Medical Centers P. C. Kansas City District Office Veterinary Drugs N/A *
July 16, 1998 Multidata Systems International Corp. Kansas City District Office Deviation from Good Manufacturing Practice N/A *
July 16, 1998 Micromedics Inc. Minneapolis District Office Medical Devices N/A *
July 16, 1998 Linvatec Corporation Florida District Office Devices/Irrigation pump N/A *
July 15, 1998 Emory Vision Correction Center Center for Devices and Radiological Health Premarket Approval Application [PMA] N/A *
July 14, 1998 Smith Russell C. D.V.M. / dba Gomers Inc. Minneapolis District Office New Animal Drug Application N/A *
July 14, 1998 Altron Inc. Minneapolis District Office Medical Devices N/A *
July 14, 1998 Tissue Medical Lasers Inc. Denver District Office Medical Devices N/A *
July 13, 1998 Pete Nunes & Son Dairies San Francisco District Office Food/Cattle N/A *
July 13, 1998 Properpak San Francisco District Office Veterinary Drugs / Finished Pharmaceuticals N/A *
July 10, 1998 Centocor Inc. Center for Biologics Evaluation and Research Deviation from applicable Standard Operating Procedures N/A *
July 10, 1998 Schwarz Pharma US operations Detroit District Office Drug Products N/A *
July 10, 1998 Toufayan Bakery Inc. New Jersey District Office Food / Cheese Products N/A *
July 09, 1998 Amersham Holdings Chicago District Office Devices/Iodine Implantable Seeds N/A *
July 09, 1998 Sunrise Farms Inc. Dallas District Office Food/Cattle N/A *
July 09, 1998 Clayton Veterinary Consultants Ltd. Dallas District Office Food/Cattle N/A *
July 09, 1998 Tri-State Livestock Dallas District Office Food / Animal for Slaughter N/A *
July 08, 1998 Alwyn Company Inc. Minneapolis District Office New Drug Application N/A *



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ICECI Warning Letters

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