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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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
August 20, 1998 Invacare Corporation Florida District Office Medical Devices N/A *
August 20, 1998 National Service Industries Inc. Florida District Office Medical Devices N/A *
August 20, 1998 Innovative Health Products Florida District Office Drug Products/Labeling N/A *
August 20, 1998 EHP Products Inc. Cincinnati District Office Labeling N/A *
August 20, 1998 Limate Corporation Center for Devices and Radiological Health Laser Products / Noncompliance N/A *
August 19, 1998 Pedreiro Arthur M. San Francisco District Office Cattle / Food N/A *
August 19, 1998 Sabratek Corporation Chicago District Office Medical Devices / [QS] Quality Systems Regulations N/A *
August 19, 1998 St. Joseph Health Center Dallas District Office Mammography Standards N/A *
August 18, 1998 Invacare Corporation Cincinnati District Office Medical Devices N/A *
August 18, 1998 VisionPlus Network Inc. San Francisco District Office Labeling/New Drug Application N/A *
August 18, 1998 Medical Packaging Technologies Inc. Atlanta District Office CGMP Deviations N/A *
August 18, 1998 MK Medical San Francisco District Office Medical Oxygen / CGMP N/A *
August 17, 1998 Concalves Manuel San Francisco District Office Food/Cattle N/A *
August 17, 1998 Lifeguard Inc. Baltimore District Office Medical Oxygen N/A *
August 17, 1998 Lincare Inc. Baltimore District Office Liquid Oxygen / CGMP N/A *
August 14, 1998 Allergy Laboratories Inc. Center for Biologics Evaluation and Research Failure to Observe Code of Federal Regulations N/A *
August 14, 1998 Ochsner Foundation Center for Devices and Radiological Health GLP N/A *
August 12, 1998 Hospital Dr. Susoni San Juan District Office Blood Products N/A *
August 12, 1998 North Atlantic Imaging Systems Inc. New England District Office Performance Standards / Diagnostic X-Ray Equipment N/A *
August 12, 1998 Campus Coach Inc. New York District Office Communicable Diseases and Interstate Conveyance N/A *



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ICECI Warning Letters

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