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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 Best Price Rx Center for Drug Evaluation and Research Unapproved/Misbranded New Drug June 28, 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 Northwest Pharmacy Center for Drug Evaluation and Research Unapproved New Drug-Misbranded June 28, 2012
May 24, 2012 Faci S.P.A. Center for Drug Evaluation and Research Failure to Register and List June 14, 2012
May 24, 2012 De Groot Sheep Inc Kansas City District Office Illegal Drug Residue July 31, 2013
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 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 22, 2012 Mc-NEIL-PPC, Inc. New Jersey District Office Adulterated Device May 22, 2014
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 Gramercy Fertility Services New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products August 03, 2012
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 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 Seco Spice Ltd. Denver District Office CGMP Regulation For Food/Adulterated October 16, 2014
May 17, 2012 Vienna Beauty Products Cincinnati District Office Cosmetics/Adulterated/Misbranded Not Issued *
May 17, 2012 Neukom Groves, Inc. Florida District Office Juice HACCP May 07, 2013
May 17, 2012 Capitol Foods, Inc. Baltimore District Office Seafood HACCP/Adulterated/Misbranded Not Issued *



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