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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2013 Warning Letters

Posted on March 19, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 06, 2013 Johann Dairy San Francisco District Office Illegal Drug Residue Not Issued *
March 06, 2013 Continental Medical Labs, Inc. Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
March 05, 2013 Roy's Fishery San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 05, 2013 Fisioline s.r.l. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
March 05, 2013 Fresenius Medical Care, North America Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 05, 2013 Primarch Manufacturing, Inc. Los Angeles District Office CGMP/Dietary Supplements/Adulterated Not Issued *
March 04, 2013 Correia Family Limited Partnership (dba Wynsum Holsteins) New England District Office Illegal Drug Residue Not Issued *
March 04, 2013 Mitsutoyo Co. Ltd., Hakodate Plant Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 04, 2013 Ivy Farms, Inc. New England District Office Illegal Drug Residue Not Issued *
March 01, 2013 Revecomed International Inc Los Angeles District Office Premarket Approval/Adulterated Not Issued *
March 01, 2013 Linet Spol. S.r.o. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded May 08, 2013
March 01, 2013 Nanhai Meishida Beauty Equipment Co., LTD Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded Not Issued *
March 01, 2013 Five Star Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
March 01, 2013 VE Valley Electronics GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
March 01, 2013 Cynergy, LLC / Dermaroller Gmbh Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
March 01, 2013 Desert Rose Manufacturing Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
February 28, 2013 Healthwest Minerals, Inc. dba Mt. Capra Products Seattle District Office CGMP/Dietary Supplements/Adulterated Not Issued *
February 28, 2013 Ben E Keith Company Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 28, 2013 Interlab S.r.l. Center for Devices and Radiological Health Medical Devices/Adulterated Not Issued *
February 26, 2013 www.topluckmall.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *


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