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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 24, 2012 FairPrice Tobacco, Inc d/b/a www. RYOCigarette.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded August 13, 2012
May 24, 2012 Good Herbs, Inc. Detroit District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 24, 2012 Best Price Rx Center for Drug Evaluation and Research Unapproved/Misbranded New Drug June 28, 2012
May 24, 2012 NatureMost of New England, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 24, 2012 DMC Medical Ltd Center for Devices and Radiological Health CGMP for Medical Devices/QS/Adulterated Not Issued *
May 23, 2012 Tango3 LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 23, 2012 RockStar, Inc. DBA Livingston Chocolate Company New Orleans District Office Unapproved Food Additive/Adulterated Not Issued *
May 22, 2012 Mc-NEIL-PPC, Inc. New Jersey District Office Adulterated Device May 22, 2014
May 22, 2012 Ernest P. Shoup Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 22, 2012 Malcolm, Matthew PhD., OTR Center for Devices and Radiological Health Clinical Investigator (Sponsor) Not Issued *
May 21, 2012 Nicho Produce Co., Inc. Dallas District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
May 21, 2012 Smith Family Frosted Foods LLC Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 18, 2012 Process Managers LLC Cincinnati District Office New Animal Drug/Adulterated October 19, 2012
May 18, 2012 Advanced OrthoPro, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 18, 2012 Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies New Orleans District Office CGMP/QSR/Medical Devices/Adulterated April 16, 2013
May 18, 2012 Seco Spice Ltd. Denver District Office CGMP Regulation For Food/Adulterated October 16, 2014
May 18, 2012 Gramercy Fertility Services New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products August 03, 2012
May 17, 2012 Vienna Beauty Products Cincinnati District Office Cosmetics/Adulterated/Misbranded Not Issued *
May 17, 2012 The Lebanon Corp., Inc. Detroit District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation September 13, 2013
May 17, 2012 Neukom Groves, Inc. Florida District Office Juice HACCP May 07, 2013



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