2010 Warning Letters

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Warning Letters issued in 2010

 

* 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 November 30, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 10, 2010	Friz-it Cold Storage, Inc.	Florida District Office	Seafood HACCP	Not Issued *
November 10, 2010	Kabco Pharmaceuticals, Inc.	New York District Office	CGMP in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
November 10, 2010	Eagle Products	Chicago District Office	Current Good Manufacturing Practice Regulations for Human Foods/Adulterated	April 04, 2012
November 09, 2010	Ultimate Formulations, Inc. dba Best Formulations	Los Angeles District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
November 09, 2010	Gunnell, Inc.	Detroit District Office	Premarket Approval/Adulterated/Misbranded	Not Issued *
November 09, 2010	Monarch Labs, LLC	Los Angeles District Office	CGMP for Medical Devices/QS/Adulterated	April 03, 2012
November 09, 2010	Lsg Sky Chefs, Inc	Dallas District Office	Seafood HACCP	Not Issued *
November 09, 2010	Race Street Foods, Inc	San Francisco District Office	Seafood HACCP	Not Issued *
November 09, 2010	Monarch Labs, LLC	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
November 08, 2010	Fish Cove, Inc.	New York District Office	Seafood HACCP	Not Issued *

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