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 09, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 29, 2010	CP Pharmaceuticals, Ltd.	Center for Drug Evaluation and Research	CGMP for Finished Pharmaceuticals/Adulterated	July 23, 2012
October 28, 2010	Wright Family Dairy	Atlanta District Office	Animals for Sale for Slaughter as Food/Adulterated	Not Issued *
October 27, 2010	Russell C. Davis Planetarium	Center for Devices and Radiological Health	Laser Product Performance Standard	Not Issued *
October 27, 2010	Mexicali Cheese Corp.	New York District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	Not Issued *
October 26, 2010	Bay Island, Inc.	Minneapolis District Office	CGMP for Foods/Adulterated	January 31, 2012
October 26, 2010	Pega Medical Inc.	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 22, 2010	Pesnusan Cia Ltda	Center for Food Safety and Applied Nutrition	CGMP for Foods/Seafood HACCP/Adulterated	April 21, 2011
October 21, 2010	Hong Chang Corporation	Los Angeles District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
October 21, 2010	Nobel Laboratories, LLC	Dallas District Office	Unapproved New Drug Promotional Claims/Misbranded	Not Issued *
October 21, 2010	Hanover Foods Corporation	Baltimore District Office	CGMP Regulation For Food/Adulterated	Not Issued *

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