• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2014 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
02/06/2014 Pulmuone Foods USA, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/05/2014 Alex Jackson and Wayne Jackson New England District Office Illegal Drug Residue Not Issued *
02/03/2014 Swiss Mountain View Egg Farm Los Angeles District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
02/03/2014 Heartsine Technologies Inc Philadelphia District Office Medical Device Reporting (MDR) Regulation 10/02/2014
02/03/2014 Orth Farms LLC New York District Office Illegal Drug Residue Not Issued *
01/31/2014 CBSCHEM LIMITED Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
01/31/2014 Exclusive Supplements, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs 12/14/2015
01/31/2014 Slim Beauty USA Kansas City District Office Unapproved New/Misbranded drugs Not Issued *
01/31/2014 NatureAll-STF Holding, LLC Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 09/15/2014
01/31/2014 Huwen Huang Import And Export Sa Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
01/30/2014 Manuel and Maria Silva Dairy San Francisco District Office Illegal Drug Residue Not Issued *
01/30/2014 Amber Technology, LLC Denver District Office New Animal Drug/Adulterated 01/21/2016
01/29/2014 Insert Depot, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/29/2014 Campbell Dairy Farm New Orleans District Office Illegal Drug Residue Not Issued *
01/29/2014 ConMed Electrosurgery Denver District Office CGMP/QSR/Medical Devices/Adulterated 08/01/2016
01/29/2014 Hillegass Dairy, LLC. Philadelphia District Office Illegal Drug Residue Not Issued *
01/28/2014 Hudson Radiology Center New Jersey District Office Mammography Quality Standards Not Issued *
01/28/2014 B & E Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
01/27/2014 Amgen, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 01/09/2015
01/27/2014 Seorak Clean Food Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
01/24/2014 C.S.O. S.R.L. Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding 08/18/2014
01/23/2014 Pacific Standard Distributors, inc Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
01/23/2014 Cotton High Tech S.L. (d/ba COHITECH) Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded 03/03/2016
01/23/2014 Mongiello Italian Cheese Specialties, Inc. dba Formaggio New York District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   08/18/2014
01/22/2014 Stanton Brothers Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
01/22/2014 Intensive Nutrition Incorporated San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
01/22/2014 Zubrzycki Homestead New York District Office Illegal Drug Residue Not Issued *
01/22/2014 Home Intensive Care Pharmacy, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
01/21/2014 Oskri Corp. Minneapolis District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated 12/19/2014
01/17/2014 Shank Farms, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
01/17/2014 Avella of Deer Valley, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 02/03/2017
01/17/2014 Baxter Healthcare Corp. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 02/08/2017
01/16/2014 www.buy-sigaretts.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/07/2014
01/16/2014 Gadre Marine Export Pvt. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
01/16/2014 Advanced Magnetic Research Institute International LLC Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
01/15/2014 Elmer Yoder Kansas City District Office Food/Egg/Prepared packed or Held Under Insanitary Conditions/Adulterated 09/29/2014
01/15/2014 Advanced Photonic Systems, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Not Issued *
01/15/2014 Yuet Heung Yuen Sauce Food (ZhuHai) Co., Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 06/21/2017
01/15/2014 Medaus, Inc. New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/15/2014 Lucky Beauty Equipment Co., LTD. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Not Issued *
01/15/2014 Recsei Laboratories, LLC Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
01/15/2014 China Daheng Group Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 07/18/2014
01/14/2014 Triangle Compounding Atlanta District Office New Drug/Misbranded Not Issued *
01/13/2014 Back To Back Medical, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/13/2014 ARO Pistachios, Inc. San Francisco District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
01/13/2014 Wild Rose Dairy, LLC Minneapolis District Office Illegal Drug Residue 02/12/2014
01/10/2014 Mercy Hospital Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
01/10/2014 Obstetrics Gynecology, Ltd Dallas District Office Mammography Quality Standards Not Issued *
01/10/2014 Jeff Mlsna Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated 01/14/2015
01/10/2014 Parisville Dairy, LLC Detroit District Office Illegal Drug Residue 07/08/2016

-