2006 Warning Letters

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Warning Letters issued in 2006

 

* 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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 28, 2006	Thomas Crab Company	Florida District Office	Seafood HACCP/Adulterated	N/A *
December 27, 2006	Applied Water Engineering, Inc.	Denver District Office	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
December 27, 2006	Tienda, Inc	Baltimore District Office	Seafood HACCP/Adulterated	N/A *
December 27, 2006	Rickland Farms, LLC	Minneapolis District Office	Animals for sale for slaughter/Adulterated	N/A *
December 26, 2006	Abraxis Bioscience, Inc.	Chicago District Office	Deviations from CGMP for Finished Pharmaceuticals	N/A *
December 26, 2006	Lee Laboratories, Inc.	Dallas District Office	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
December 21, 2006	Colusa Regional Medical Center	San Francisco District Office	Mammography Quality Standards	N/A *
December 21, 2006	Palmer Farms	New England District Office	Animals for sale for slaughter/Adulterated	N/A *
December 21, 2006	Sam's Homemade Cheesecake Inc.	Los Angeles District Office	CGMP Regulation For Food/Adulterated	N/A *
December 20, 2006	TMJ Implants, Inc.	Center for Devices and Radiological Health	Lacks Premarket Approval Application/Adulterated/Misbranded	N/A *
December 20, 2006	Sharma, Baljit K., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 20, 2006	Williams Farms Inc.	New England District Office	Animals for sale for slaughter/Adulterated	N/A *
December 18, 2006	Biora AB	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
December 18, 2006	FUZE Beverages, LLC	New Jersey District Office	CGMP/Food Labeling/New Drug	N/A *
December 15, 2006	Kingmar Seafood Corporation	Florida District Office	Seafood HACCP/Adulterated	N/A *
December 12, 2006	GSCM Ventures Inc.	San Francisco District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
December 12, 2006	LCDG Enterprise	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 12, 2006	Viasys Healthcare	Cincinnati District Office	CGMP/Requirements for Medical Devices/QSR/Adulterated	N/A *
December 08, 2006	Schumacher's	New York District Office	Illegal Drug Residue	N/A *
December 08, 2006	Quick-Fill Mobile Oxygen, Inc.	New Orleans District Office	CGMP for Finished Pharmaceuticals/Adulterated	N/A *
December 08, 2006	Nasiff Associates, Inc.	New York District Office	CGMP/Adulterated	N/A *
December 08, 2006	Ganeden Biotech Inc.	Cincinnati District Office	Misbranded/Labeling/Unauthorized Health Claims	N/A *
December 08, 2006	MRL Inc.	Chicago District Office	CGMP For Medical Device Report/Adulterated	N/A *
December 08, 2006	Ratcliff, David C, M.D.	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
December 08, 2006	Biotecx Laboratories, Inc.	Dallas District Office	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
December 06, 2006	INCELL Corporation, LLC	Center for Biologics Evaluation and Research	GLP/Bioresearch Monitoring Program/Investigational drugs	N/A *
December 04, 2006	Ritch, Robert M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 04, 2006	New England Compounding Center	New England District Office	Pharmacy Compounding/New Drug/Misbranded	N/A *
December 04, 2006	University Pharmacy	Denver District Office	Pharmacy Compounding/New Drug/Misbranded	N/A *
December 04, 2006	Customs Scripts Pharmacy	Florida District Office	Pharmacy Compounding/New Drug/Misbranded	N/A *
December 04, 2006	Triangle Compounding Pharmacy	Atlanta District Office	Pharmacy Compounding/New Drug/Misbranded	N/A *
December 04, 2006	Hal's Compounding Pharmacy, Inc	Center for Drug Evaluation and Research	Pharmacy Compounding/New Drug/Misbranded	N/A *
December 04, 2006	Feenstra, John	Seattle District Office	Illegal Drug Residue	N/A *
December 04, 2006	Ritch, Robert MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 04, 2006	Lamb Farms, Inc.	New York District Office	Illegal Drug Residue	N/A *
December 01, 2006	Spoonamore Drug Co., Inc.	Cincinnati District Office	Pharmacy Compounding/New Drug/Adulterated/Misbranded	N/A *
November 30, 2006	C.R.D. Group, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
November 29, 2006	Skytron	Detroit District Office	Current Good Manufacturing Requirements for Medical Devices/Adulterated	N/A *
November 29, 2006	Steris Corporation	New Orleans District Office	Medical Device Reporting (MDR) Regulation Misbranded/Adulterated	N/A *
November 29, 2006	HemoSense, Inc.	San Francisco District Office	CGMP for Medical Devices/QS/Adulterated	N/A *
November 28, 2006	Honolulu Fish & Seafood Corporation	San Francisco District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
November 27, 2006	Nestle S.A.	Minneapolis District Office	Infant Formula/Labeling/Misbranded	N/A *
November 27, 2006	Health Dimensions, Inc.	Detroit District Office	Pharmacy Compounding/New Drug/Misbranded	N/A *
November 27, 2006	Bessinger Pickle Company, Inc.	Detroit District Office	CGMP Manufacturing, Packing, or Holding Human Food/Adulterated	N/A *
November 27, 2006	Craftmatic Organization, Inc.	Philadelphia District Office	CGMP Requirements for Medical Devices/Quality System Regulation	N/A *
November 22, 2006	Conti, Ralph M., M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 22, 2006	Meyer Farm	Minneapolis District Office	Illegal Drug Residue /Adulterated	N/A *
November 21, 2006	Nardi, Claudia	Center for Devices and Radiological Health	Lacks Premarket Approval Application	N/A *
November 21, 2006	Natren Inc.	Los Angeles District Office	Labeling/Promotional Claims False & Misleading/Misbranded/Adulterated	N/A *
November 21, 2006	Dupaco, Inc.	Los Angeles District Office	Current Good Manufacturing Requirements for Medical Devices/Adulterated	N/A *

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