2001 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 2001

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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 July 23, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
August 22, 2001	Ortho Development Corporation	Denver District Office	Quality System/Good Manufacturing Practice for Medical Devices Regulation/Orthopedic Implants	N/A *
August 21, 2001	Laborde Diagnostics- South College	New Orleans District Office	Mammography Quality Standards	N/A *
August 21, 2001	M. Slavin & Sons, Ltd.	New York District Office	Seafood HACCP	N/A *
August 21, 2001	Advance Radiological Center	Detroit District Office	Mammography Quality Standards	N/A *
August 21, 2001	M. Slavin & Sons, Ltd.	New York District Office	Seafood HACCP	N/A *
August 21, 2001	Splintek-PP, Inc.	Center for Devices and Radiological Health	Premarket Notification Procedures/Not Substantially Equivalent/Adulterated/Misbranded	N/A *
August 21, 2001	The Hyland Co., Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
August 21, 2001	Agroaltos, S.A.	Florida District Office	Snow Peas/Presented for Destruction are not the Original Product	N/A *
August 21, 2001	Shelby Baptist Medical Center	New Orleans District Office	Mammography Quality Standards	N/A *
August 21, 2001	Lentz, Meredith R., M.D.	Center for Devices and Radiological Health	Sponsor/Monitor/Contract Research Organization	N/A *
August 21, 2001	Southern Aire Seafood, Inc.	New Orleans District Office	Seafood HACCP	N/A *
August 20, 2001	Greenville Loop Seafood	Atlanta District Office	Seafood HACCP	N/A *
August 17, 2001	Baker's Pharmacy	Chicago District Office	cGMP/Finished Pharmaceutical/Oxygen Repacking Facility/Adulterated	N/A *
August 17, 2001	Irvine Medical Center	Los Angeles District Office	Mammography Quality Standards	N/A *
August 17, 2001	Oratec Interventions, Incorporated	Center for Devices and Radiological Health	Labeling/Premarket Notification Procedure/Adulterated/Misbranded	N/A *
August 17, 2001	Kingston Diagnostic Center	New York District Office	Mammography Quality Standards	N/A *
August 17, 2001	Kingston Diagnostic Center	New York District Office	Mammography Quality Standards	N/A *
August 17, 2001	Foods C'Est Bon, Limited	New Orleans District Office	Seafood HACCP	N/A *
August 17, 2001	Copley Feed & Supply	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
August 17, 2001	Daebok Restaurant	New York District Office	Seafood HACCP	N/A *

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