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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
November 18, 2013 ACPETAMAR De R.L. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 18, 2013 Ka-vern Farms New York District Office Illegal Drug Residue Not Issued *
November 15, 2013 Kootenai Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB)/Investigational Device Exemptions Not Issued *
November 14, 2013 Mectra Labs, Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
November 14, 2013 Berlin Valley Farm Cincinnati District Office Illegal Drug Residue Not Issued *
November 14, 2013 Ed Vander Woude Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
November 14, 2013 Cheen Houng Enterprise Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
November 14, 2013 Mountain Laurel Log Homes and Land, Inc. dba Kickin Mule Atlanta District Office Acidified Foods/Adulterated Not Issued *
November 14, 2013 Clinical Lasers, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 14, 2013 Ad-Tech Medical Instrument Corporation Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 13, 2013 David C. Kauffman Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 08, 2013 Northwest Veterinary Associates, Inc. New England District Office Animal Drugs/Adulterated   Not Issued *
November 07, 2013 Irvington Seafood Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 07, 2013 HONG NGOC PTE Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 04, 2013 www.tobaccocountry.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 01, 2013 Resers Fine Foods Inc Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
November 01, 2013 Luis Dairy San Francisco District Office New Animal Drug/Adulterated Not Issued *
October 31, 2013 Elam Fisher Baltimore District Office Illegal Drug Residue Not Issued *
October 29, 2013 www.snusdirect.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
October 29, 2013 Browne Trading Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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