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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 07, 2014 Korea United Pharm Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
August 06, 2014 Vernon W. Zimmerman Philadelphia District Office Illegal Drug Residue Not Issued *
August 05, 2014 Garden of Flavor LLC Cincinnati District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 05, 2014 Goodlife Juices Philadelphia District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 05, 2014 www.smokesfourless.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded December 02, 2014
August 05, 2014 Engineering Nutrition Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
August 04, 2014 Oberholtzer, Joseph N. Philadelphia District Office Illegal Drug Residue Not Issued *
August 01, 2014 Peter Bacle dba Stock Island Lobster Company Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 01, 2014 Geetanjali Inc., d/b/a Tobacco World Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 04, 2014
July 31, 2014 Faihopity Farms, LP Philadelphia District Office Illegal Drug Residue Not Issued *
July 31, 2014 Dean and Jean Mikalunas New York District Office New Animal Drug/Adulterated Not Issued *
July 31, 2014 Wang Globalnet New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 31, 2014 Iberia Foods Company of New York, Inc New York District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
July 30, 2014 Taiyo Seafood NY Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 30, 2014 Plexus Worldwide Inc Los Angeles District Office New Drug/Misbranded Not Issued *
July 29, 2014 MKL DIAGNOSTICS AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 29, 2014 Imer Barton New York District Office Illegal Drug Residue Not Issued *
July 29, 2014 M & C Catering LLC Atlanta District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated August 21, 2014
July 28, 2014 Dwyer & Manning Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded January 15, 2015
July 28, 2014 Connecticut Valley Tobacconist, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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