1997 Warning Letters

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Tobacco Retailer Warning Letters

 

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

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