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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 07, 2013 www.djarumblack-clovecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 07, 2013 Machado Dairy Farms Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
March 07, 2013 Lodato Gennaro & C S.p.A. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
March 06, 2013 Shatila Food Products, Inc. Detroit District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
March 06, 2013 Jerland Farm Minneapolis District Office Illegal Drug Residue June 10, 2013
March 06, 2013 Continental Medical Labs, Inc. Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated November 19, 2013
March 06, 2013 Stryker Instruments Div. of Stryker Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated January 14, 2014
March 06, 2013 Johann Dairy San Francisco District Office Illegal Drug Residue 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 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 March 25, 2014
March 05, 2013 Fisioline s.r.l. Center for Devices and Radiological Health Quality System Regulation/Medical Device Reporting/Adulterated Not Issued *
March 04, 2013 Ivy Farms, Inc. 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 Correia Family Limited Partnership (dba Wynsum Holsteins) New England District Office Illegal Drug Residue Not Issued *
March 01, 2013 Desert Rose Manufacturing Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 01, 2013 VE Valley Electronics GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded January 23, 2014
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 Five Star Dairy #2 San Francisco District Office Illegal Drug Residue Not Issued *
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 *



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