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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2017 Warning Letters

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Letter Issue Date Company Name Issuing Office Subject Close Out Date
08/02/2017 Maplerose Enterprises, LLC, dba Pencol Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
08/02/2017 Cellex-C International Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/02/2017 Homeolab USA Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Refused Inspection Not Issued *
08/02/2017 Coleman Peanut Company Baltimore District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
08/01/2017 Ballard Plaza Pharmacy I, Inc. Los Angeles District Office Compounding Pharmacy/Adulteration/Misbranding Not Issued *
08/01/2017 Foshan Flying Medical Products Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/01/2017 Armada Nutrition Cincinnati District Office CGMP/Dietary Supplement/Adulterated Not Issued *
07/31/2017 Safe Way Ecig, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Broke Dick Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Vape Goddess LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 AspireCig LTD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Green Leaf Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/31/2017 Freshvaping.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Skin Sciences Laboratory, Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
07/28/2017 Prodigy Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Vapor Alley Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Nuports Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 EzyPayway.com Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 Royal Smoke LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/28/2017 EJuice.deals Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/25/2017 Absonutrix Atlanta District Office New Drug/Labeling/False & Misleading Claims Not Issued *
07/24/2017 Village Pharmacy New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
07/21/2017 Medical Center Pharmacy, Inc. Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
07/20/2017 Option Care New Jersey District Office Drug Product/Adulterated Not Issued *
07/20/2017 W & C dba The Apothecary Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
07/19/2017 Be Natural Organics Chicago District Office New Drug/Labeling/Misbranded Not Issued *
07/18/2017 Vedame Oils LLC dba UMA Oils Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
07/17/2017 Sage Products Inc Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/17/2017 R & R Holsteins, LLC (Dairy #3) Seattle District Office New Animal Drug/Adulterated Not Issued *
07/17/2017 Algunas Inc., dba Woodland Hills Compounding Pharmacy Los Angeles District Office Unapproved New Drug/Compounding/Misbranding/Adulterated Not Issued *
07/12/2017 Sinosharp Import & Export Co Ltd New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/12/2017 Whitehall/Div of Acorn Engineering Co Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/11/2017 Kretek International, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/11/2017 Black Seed Herb, Inc. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
07/11/2017 National Biological Corp New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/06/2017 Tubilux Pharma Spa Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/06/2017 Irie Star LLC Kansas City District Office New Drug/Labeling/Misbranded Not Issued *
07/06/2017 APS BioGroup, Inc Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
07/06/2017 Center for Reproductive Health Joliet IVF LLC Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
07/05/2017 Vista Pharmaceuticals Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
07/05/2017 K & B Company, Inc Denver District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
06/30/2017 Nature's Health Company, LLC Cincinnati District Office New Drug/Misbranded Not Issued *
06/29/2017 Evanger's Dog & Cat Food Co Chicago District Office Acidified Foods/Adulterated Not Issued *
06/29/2017 God Quest, Inc. d/b/a Creation Today San Juan District Office New Drug/Misbranded Not Issued *
06/29/2017 ChemRite CoPac, Inc. Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/28/2017 Jerald and Janine Stewart Farm Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated Not Issued *
06/28/2017 Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy Dallas District Office New Drug/Misbranded Not Issued *
06/27/2017 New Capstone, Inc Los Angeles District Office New Drug/Misbranded Not Issued *
06/22/2017 Shandong Analysis and Test Center Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection Not Issued *
06/21/2017 Vapor Stix Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

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