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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
November 18, 1997 Aloma Winter Park Medical Ctr. [ARCHIVED] Florida District Office Mammography Standards N/A *
November 18, 1997 Joe's Cajun Seafood [ARCHIVED] New Orleans District Office Food/Crabmeat N/A *
November 17, 1997 Allergologisk Laboratorium A/S [ARCHIVED] Center for Biologics Evaluation and Research Drug Products/Testing N/A *
November 17, 1997 Cabral Antonio M. [ARCHIVED] San Francisco District Office Food/Cattle N/A *
November 17, 1997 Haemonetics Corporation [ARCHIVED] New England District Office Devices/Plasma Collection Systems N/A *
November 14, 1997 CryoLife Inc. [ARCHIVED] Florida District Office Devices/Carotid Shunts N/A *
November 14, 1997 Advanced Respiratory Care [ARCHIVED] Florida District Office Medical Oxygen N/A *
November 13, 1997 Research Foundation for Microbial Diseases of Osaka [ARCHIVED] Center for Biologics Evaluation and Research Drug Products/Testing N/A *
November 13, 1997 Center for Corrective Eye Surgery [ARCHIVED] Center for Devices and Radiological Health Devices/Laser Systems N/A *
November 13, 1997 Lenco's Products [ARCHIVED] New York District Office Over the Counter Drug Products N/A *
November 13, 1997 Milky Way Dairy [ARCHIVED] San Francisco District Office Food/Cattle N/A *
November 07, 1997 Hyperion Inc. [ARCHIVED] Florida District Office Devices/Micro Reader III and HyPrep Plus N/A *
November 07, 1997 Van Der Geest Dairy Cattle Inc. [ARCHIVED] Minneapolis District Office Food/Cattle N/A *
November 07, 1997 Elan Corporation plc [ARCHIVED] Atlanta District Office Drug Products N/A *
November 07, 1997 Gelco Diagnostices Inc. [ARCHIVED] New Orleans District Office In Vitro Diagnostic Products N/A *
November 06, 1997 DePuy Motech [ARCHIVED] Center for Devices and Radiological Health Devices/Cervical Plate Systems N/A *
November 06, 1997 Comtrad Industries Incorporated [ARCHIVED] Center for Devices and Radiological Health Devices/Hearing Aid N/A *
November 05, 1997 Victoreen Inc. [ARCHIVED] Cincinnati District Office Devices/Electrometers Dosemeters N/A *
November 05, 1997 Springfield Imaging & Diagnostic Center [ARCHIVED] Chicago District Office Mammography Standards N/A *
November 05, 1997 Camnitz Leonard D.O. [ARCHIVED] Philadelphia District Office Mammography Standards N/A *



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