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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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1997 Warning Letters

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Warning Letters for 1997

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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
December 19, 1997 Carl's Medical Home Care Inc. [ARCHIVED] Cincinnati District Office Devices/Resuscitators N/A *
December 18, 1997 First Community Care Inc. [ARCHIVED] Buffalo District Office Medical Oxygen N/A *
December 18, 1997 Shaw Oxygen Co. Inc. [ARCHIVED] New Orleans District Office Liquid Oxygen N/A *
December 18, 1997 American Air Gases [ARCHIVED] Cincinnati District Office Drug Products N/A *
December 18, 1997 Sterile Reprocessing Services [ARCHIVED] Dallas District Office Medical Devices N/A *
December 18, 1997 Convacare Services Inc. [ARCHIVED] Detroit District Office Drug Products N/A *
December 18, 1997 Sor-Van Radiation Ltd. [ARCHIVED] Center for Devices and Radiological Health Devices N/A *
December 17, 1997 American Medical Laboratories Incorporated [ARCHIVED] Baltimore District Office Devices/anti-HIV-1 Western Blot N/A *
December 17, 1997 Gourmet Bakery Shoppes Incorporated [ARCHIVED] Baltimore District Office Food/Sanitation N/A *
December 17, 1997 McAllen Miller International Airport [ARCHIVED] Dallas District Office Insanitary Conditions N/A *
December 17, 1997 Port of Brownsville Navigation [ARCHIVED] Dallas District Office Insanitary Conditions N/A *
December 16, 1997 Seikagaku Corporation [ARCHIVED] Center for Biologics Evaluation and Research Biologics N/A *
December 16, 1997 Medenet Inc. d.b.a. Advantage Care [ARCHIVED] Cincinnati District Office Medical Oxygen N/A *
December 16, 1997 Manatee Respiratory Services [ARCHIVED] Florida District Office Medical Oxygen N/A *
December 16, 1997 DMI Enterprises Inc. [ARCHIVED] Baltimore District Office Food N/A *
December 16, 1997 Aprile Farms Inc. [ARCHIVED] Florida District Office Food/Cattle N/A *
December 16, 1997 Ortho-Cycle Company Inc. [ARCHIVED] Florida District Office Medical Devices N/A *
December 16, 1997 Becton Dickinson Microbiology Systems [ARCHIVED] Baltimore District Office Medical Devices N/A *
December 16, 1997 Empire Medical Building Associates of Rockaway Inc. [ARCHIVED] New York District Office Mammography Standards N/A *
December 16, 1997 J & J SnackFoods Corporation [ARCHIVED] New Jersey District Office Labeling N/A *



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ICECI Warning Letters

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