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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 

Posted on May 26, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 24, 1997 L'Ceiba Distributors San Juan District Office Labeling/Honey N/A *
November 21, 1997 Hologic Inc. New England District Office Devices/Bone Densitometers N/A *
November 21, 1997 Zoll Medical Corporation New England District Office Devices/Defibrillators N/A *
November 21, 1997 Kaiser Farms Inc. Minneapolis District Office Drug Products N/A *
November 21, 1997 Cell Marque Corporation Dallas District Office In Vitro Diagnostic Products N/A *
November 21, 1997 Tuality Community Hospital Seattle District Office Mammography Standards N/A *
November 21, 1997 Violet Dock Port Inc. New Orleans District Office Vessel Watering Points N/A *
November 21, 1997 Browne Kevin Center for Devices and Radiological Health Clinical Investigator N/A *
November 20, 1997 Connaught Laboratories Inc. Center for Biologics Evaluation and Research Biologics N/A *
November 20, 1997 MG Industries New Orleans District Office Medical Oxygen and Nitrogen N/A *
November 20, 1997 King and Prince Seafood Corporation Florida District Office Food/Shrimp N/A *
November 20, 1997 BRI-AL L.L.C. Chicago District Office Food N/A *
November 20, 1997 Ward Douglas M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
November 19, 1997 ProSun Tanning Industries Incorporated/dba Hapro Center for Devices and Radiological Health Devices/Sunlamps N/A *
November 19, 1997 Two Thumbs Up Tanning Baltimore District Office Tanning Beds N/A *
November 19, 1997 Nissho Corporation Center for Devices and Radiological Health Hemodialysis Devices N/A *
November 18, 1997 Greyhound Lines Incorporated Baltimore District Office Backflow Prevention Device N/A *
November 18, 1997 Joe's Cajun Seafood New Orleans District Office Food/Crabmeat N/A *
November 18, 1997 Aloma Winter Park Medical Ctr. Florida District Office Mammography Standards N/A *
November 18, 1997 Lee Pharmaceuticals Los Angeles District Office Drug Products/GMP N/A *


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ICECI Warning Letters

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