FDA or food and drug administration

Regulations just in April of 2015

2015 Warning Letters

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Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date

April 14, 2015http://www.cigs7.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *

April 10, 2015Martech Mdi IncPhiladelphia District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 10, 2015Quality Electrodynamics LLCCincinnati District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 09, 2015Fatima BrothersNew York District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *

April 08, 2015Region Care, Inc.New York District OfficeCompounding Pharmacy/Adulteration/MisbrandingNot Issued *

April 08, 2015Thermedx LLCCincinnati District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 07, 2015Better Health Systems, IncDenver District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 07, 2015Providence DairyDenver District OfficeIllegal Drug ResidueNot Issued *

April 06, 2015Joseph Timothy SmartAtlanta District OfficeIllegal Drug ResidueNot Issued *

April 06, 2015Whole Leaf Tobacco (Don Carey)Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *

April 06, 2015Yunnan Hande Bio-Tech. Co. Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *

April 03, 2015Galena BioPharma IncSeattle District OfficePostmarketing Adverse Drug Experience (PADE) Reporting RequirementsNot Issued *

April 03, 2015Visionary Contact Lens dba VisionaryLos Angeles District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 02, 2015Dr. KCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Section 301(tt) ViolationNot Issued *

April 02, 2015Hiland's CigarsCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *

April 02, 2015Knoxville Vapor LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Section 301(tt) ViolationNot Issued *

April 02, 2015Medical Components, Inc dba MedCompPhiladelphia District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *

April 02, 2015Pipe World IncCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *

April 02, 2015Silva Dairy, Jesse P.San Francisco District OfficeIllegal Drug ResidueNot Issued *

April 02, 2015www.vaperz.co.ukCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Section 301(tt) ViolationNot Issued *

Enforcement Statistics

From 2009-2012, FDA Investigations resulted in


1,259 Arrests

1,274 Convictions

$10.6 Billion in Fines and Restitution