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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 03, 2014 Swiss Mountain View Egg Farm Los Angeles District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
February 03, 2014 Heartsine Technologies Inc Philadelphia District Office Medical Device Reporting (MDR) Regulation October 02, 2014
February 03, 2014 Orth Farms LLC New York District Office Illegal Drug Residue Not Issued *
January 31, 2014 CBSCHEM LIMITED Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
January 31, 2014 Exclusive Supplements, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs December 14, 2015
January 31, 2014 Slim Beauty USA Kansas City District Office Unapproved New/Misbranded drugs Not Issued *
January 31, 2014 NatureAll-STF Holding, LLC Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated September 15, 2014
January 31, 2014 Huwen Huang Import And Export Sa Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 30, 2014 Manuel and Maria Silva Dairy San Francisco District Office Illegal Drug Residue Not Issued *
January 30, 2014 Amber Technology, LLC Denver District Office New Animal Drug/Adulterated January 21, 2016
January 29, 2014 Insert Depot, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 29, 2014 Campbell Dairy Farm New Orleans District Office Illegal Drug Residue Not Issued *
January 29, 2014 ConMed Electrosurgery Denver District Office CGMP/QSR/Medical Devices/Adulterated August 01, 2016
January 29, 2014 Hillegass Dairy, LLC. Philadelphia District Office Illegal Drug Residue Not Issued *
January 28, 2014 Hudson Radiology Center New Jersey District Office Mammography Quality Standards Not Issued *
January 28, 2014 B & E Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
January 27, 2014 Amgen, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated January 09, 2015
January 27, 2014 Seorak Clean Food Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 24, 2014 C.S.O. S.R.L. Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding August 18, 2014
January 23, 2014 Pacific Standard Distributors, inc Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
January 23, 2014 Cotton High Tech S.L. (d/ba COHITECH) Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded March 03, 2016
January 23, 2014 Mongiello Italian Cheese Specialties, Inc. dba Formaggio New York District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   August 18, 2014
January 22, 2014 Stanton Brothers Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
January 22, 2014 Intensive Nutrition Incorporated San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 22, 2014 Zubrzycki Homestead New York District Office Illegal Drug Residue Not Issued *
January 22, 2014 Home Intensive Care Pharmacy, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 21, 2014 Oskri Corp. Minneapolis District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated December 19, 2014
January 17, 2014 Shank Farms, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
January 17, 2014 Avella of Deer Valley, Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded February 03, 2017
January 17, 2014 Baxter Healthcare Corp. Chicago District Office CGMP/QSR/Medical Devices/Adulterated February 08, 2017
January 16, 2014 www.buy-sigaretts.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 07, 2014
January 16, 2014 Gadre Marine Export Pvt. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 16, 2014 Advanced Magnetic Research Institute International LLC Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
January 15, 2014 Elmer Yoder Kansas City District Office Food/Egg/Prepared packed or Held Under Insanitary Conditions/Adulterated September 29, 2014
January 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 *
January 15, 2014 Yuet Heung Yuen Sauce Food (ZhuHai) Co., Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 15, 2014 Medaus, Inc. New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
January 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 *
January 15, 2014 Recsei Laboratories, LLC Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
January 15, 2014 China Daheng Group Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated July 18, 2014
January 14, 2014 Triangle Compounding Atlanta District Office New Drug/Misbranded Not Issued *
January 13, 2014 Back To Back Medical, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 13, 2014 ARO Pistachios, Inc. San Francisco District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
January 13, 2014 Wild Rose Dairy, LLC Minneapolis District Office Illegal Drug Residue February 12, 2014
January 10, 2014 Mercy Hospital Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
January 10, 2014 Obstetrics Gynecology, Ltd Dallas District Office Mammography Quality Standards Not Issued *
January 10, 2014 Jeff Mlsna Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated January 14, 2015
January 10, 2014 Parisville Dairy, LLC Detroit District Office Illegal Drug Residue July 08, 2016
January 09, 2014 Mega Electronics Ltd. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded October 27, 2015
January 08, 2014 www.gotlandssnus.com, www.jakobssonssnus.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 25, 2014

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