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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
October 02, 2013 Rocklan Farm New York District Office Illegal Drug Residue Not Issued *
October 01, 2013 Poultry Products Company, Inc dba Poultry Products Northeast New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 01, 2013 Earl Wolfe Farms Inc Cincinnati District Office Illegal Drug Residue Not Issued *
September 30, 2013 King Systems Corp. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 30, 2013 El Campestre Distributor Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 30, 2013 Dennis J. Hurwitz, M.D. Center for Devices and Radiological Health Institutional Review Board (IRB)/Investigational Device Exemptions Not Issued *
September 27, 2013 www.indo-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded December 04, 2013
September 26, 2013 Globus Medical, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated March 18, 2014
September 26, 2013 Double W Dairy Denver District Office Illegal Drug Residue September 29, 2014
September 25, 2013 Jin Han International, Inc. (dba Pacific Foods Co.) Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 25, 2013 Standard Homeopathic Company, Inc. Los Angeles District Office False & Misleading Claims/Misbranded Not Issued *
September 24, 2013 NIDEK Co., Ltd., Hamacho Plant Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
September 24, 2013 A&G Dairy Farms San Francisco District Office Illegal Drug Residue Not Issued *
September 24, 2013 Nephron Pharmaceuticals Corp. Florida District Office New Drug/Misbranded Not Issued *
September 24, 2013 Rich-Lou Farms Philadelphia District Office Illegal Drug Residue February 24, 2014
September 23, 2013 American Aesthetics Medical Supply, Inc. Dallas District Office Medical Device Reporting/Misbranded Not Issued *
September 23, 2013 Batrik Medical Mfg., Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
September 23, 2013 Haciendas Morales dba Granja Avicola Morales San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
September 20, 2013 Fomar Import/Export Inc. Dallas District Office Insanitary Conditions/Adulterated Not Issued *
September 20, 2013 Capillus LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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