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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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Tobacco Retailer 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 02, 1997 Medtronic Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
November 28, 1997 Wells Johnson Co. [ARCHIVED] Los Angeles District Office Devices/Surgical Instruments N/A *
November 28, 1997 Peninsula Laboratories Inc. [ARCHIVED] Center for Biologics Evaluation and Research Biologics N/A *
November 28, 1997 Morwell Corporation [ARCHIVED] Los Angeles District Office Devices/Surgical Instruments N/A *
November 28, 1997 Grant Regional Health Center [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
November 26, 1997 Purepac Pharmaceutical Co. [ARCHIVED] New Jersey District Office Drug Products N/A *
November 26, 1997 Metropolitan Hospital Center [ARCHIVED] New York District Office Mammography Standards N/A *
November 26, 1997 Seafood International Distributors Inc. [ARCHIVED] New Orleans District Office Food/Crabmeat N/A *
November 26, 1997 John Deere Family Healthplan [ARCHIVED] Nashville District Office Mammography Standards N/A *
November 25, 1997 Graphic Controls Corporation [ARCHIVED] Atlanta District Office Medical Devices N/A *
November 25, 1997 Women's Diagnostic Clinic Inc. [ARCHIVED] Cincinnati District Office Mammography Standards N/A *
November 25, 1997 Dade Behring Incorporated [ARCHIVED] San Francisco District Office Devices/Diagnostic Systems N/A *
November 25, 1997 Vas-Cath Incorporated [ARCHIVED] Center for Devices and Radiological Health Devices/Catheters N/A *
November 25, 1997 Suburban General Hospital [ARCHIVED] Philadelphia District Office Blood Products N/A *
November 24, 1997 Danville Elks Blood Bank Inc. [ARCHIVED] Chicago District Office Hospital Blood Bank N/A *
November 24, 1997 Easton Hospital [ARCHIVED] Philadelphia District Office Mammography Standards N/A *
November 24, 1997 Bayer Corporation [USA] [ARCHIVED] Chicago District Office In-Vitro Diagnostics N/A *
November 24, 1997 L'Ceiba Distributors [ARCHIVED] San Juan District Office Labeling/Honey N/A *
November 24, 1997 Halcon Bakers Inc. [ARCHIVED] San Juan District Office Labeling/Honey N/A *
November 24, 1997 Jersey City Medical Center [ARCHIVED] New Jersey District Office Mammography Standards N/A *



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ICECI Warning Letters

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