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 May 18, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 10, 2010	Dolce, L.L.C.	Cincinnati District Office	Seafood HACCP/Insanitary Conditions/Adulterated	Not Issued *
May 10, 2010	Len-acres	Seattle District Office	Illegal Drug Residue	Not Issued *
May 10, 2010	Braintree Laboratories Inc	New England District Office	CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated	April 27, 2011
May 10, 2010	Willamette Shelling Inc	Seattle District Office	CGMP Regulation For Food/Adulterated	Not Issued *
May 10, 2010	Aurora Ridge Dairy, LLC	New York District Office	Illegal Drug Residue	Not Issued *
May 10, 2010	Service Smoked Fish Corp	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
May 10, 2010	Midstate Veterinary Services, PLLC	New York District Office	Illegal Drug Residue	Not Issued *
May 07, 2010	Medtronic Navigation, Inc	Denver District Office	Medical Device/Lacks Premarket Approval/Adulterated/Misbranded	Not Issued *
May 06, 2010	C.V. Foods Corporation, DBA Yo Lily Cheesecake Co.	Los Angeles District Office	CGMP Requirement for Food Manufacturing/Adulterated	Not Issued *
May 03, 2010	Trilliant Surgical, LTD	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *

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