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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
August 09, 2013 Electro Medical, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 09, 2013 Promed Exports Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 09, 2013 Native American Enterprises, LLC Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
August 09, 2013 Hair Labs International, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 09, 2013 LifeServe Blood Center Kansas City District Office CGMP Blood & Blood Components/Adulterated July 02, 2014
August 08, 2013 Carry All Provisions Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions February 07, 2014
August 08, 2013 The Reynolds Office of Health and Nutrition Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) April 09, 2014
August 08, 2013 Village Farm Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
August 08, 2013 Oxyhealth, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) April 08, 2014
August 08, 2013 Hyperbaric Options Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
August 08, 2013 Pressure Tech Inc Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) April 09, 2014
August 08, 2013 Healing Dives, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
August 07, 2013 Vibrant Life Los Angeles District Office New Drug/Labeling/Misbranded March 19, 2014
August 06, 2013 Huestis Machine Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated May 21, 2014
August 05, 2013 NALMA, S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 05, 2013 Country Bakery, LLC Denver District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions December 09, 2013
August 02, 2013 Posh Chemicals Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/HPLC Not Issued *
August 02, 2013 DNE Nutraceuticals Inc. New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
August 01, 2013 Lumina Health Products, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
August 01, 2013 St Joseph Mercy Oakland IRB Center for Devices and Radiological Health Institutional Review Board (IRB)/Investigational Device Exemptions Not Issued *



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