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Violation Tracker Agency Summary Page

Agency Name: Food and Drug Administration
Penalty Total since 2000: $19,513,219,130
Number of Records: 60
Note: The parent penalty totals are adjusted to account for the fact that the list of individual entries below may include both agency records and settlement announcements for the same case; or else a penalty covering multiple locations may be listed in the individual records for each of the facilities. Duplicate penalty amounts are marked with an asterisk in the individual records list below.
Top 10 Current Parent CompaniesTotal Penalty $Number of Records
GSK plc$3,750,000,0002
Pfizer$3,320,400,0006
AbbVie$2,430,500,0005
Johnson & Johnson$2,392,200,0005
Eli Lilly$1,451,000,0002
Merck$950,000,0001
Amgen$762,000,0001
Merck KGaA (EMD)$704,000,0001
AstraZeneca$520,000,0001
Alphabet Inc.$500,000,0001

Individual Penalty Records:

Click on the company or penalty amount for more information on each case. Click on the current parent name to reach the summary page for that parent company.

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CompanyCurrent ParentCurrent Parent IndustryPrimary Offense TypeYearPenalty Amount sort icon
GlaxoSmithKline LLCGSK plcpharmaceuticalsoff-label or unapproved promotion of medical products2012$3,000,000,000
Pfizer Inc.Pfizerpharmaceuticalsoff-label or unapproved promotion of medical products2009$2,300,000,000
Johnson & JohnsonJohnson & Johnsonpharmaceuticalsoff-label or unapproved promotion of medical products2013$2,200,000,000
Abbott Laboratories Inc.AbbViepharmaceuticalsoff-label or unapproved promotion of medical products2012$1,500,000,000
Eli Lilly and CompanyEli Lillypharmaceuticalsoff-label or unapproved promotion of medical products2009$1,415,000,000
Merck, Sharp & DohmeMerckpharmaceuticalsoff-label or unapproved promotion of medical products2011$950,000,000
Amgen Inc.Amgenpharmaceuticalsoff-label or unapproved promotion of medical products2012$762,000,000
SB Pharmco Puerto Rico Inc.GSK plcpharmaceuticalsdrug or medical equipment safety violation2010$750,000,000
Serono, S.A.Merck KGaA (EMD)pharmaceuticalsoff-label or unapproved promotion of medical products2005$704,000,000
Allergan Inc.AbbViepharmaceuticalsoff-label or unapproved promotion of medical products2010$600,000,000
AstraZeneca LPAstraZenecapharmaceuticalsoff-label or unapproved promotion of medical products2010$520,000,000
Ranbaxy USA Inc.Sun Pharmaceuticalspharmaceuticalsdrug or medical equipment safety violation2013$500,000,000
Google Inc.Alphabet Inc.information technologyoff-label or unapproved promotion of medical products2011$500,000,000
Wyeth Pharmaceuticals Inc.Pfizerpharmaceuticalsoff-label or unapproved promotion of medical products2013$490,900,000
Warner-LambertPfizerpharmaceuticalsoff-label or unapproved promotion of medical products2004$430,000,000
Cephalon IncTeva Pharmaceutical Industriespharmaceuticalsoff-label or unapproved promotion of medical products2008$425,000,000
Novartis Pharmaceuticals CorporationNovartispharmaceuticalsoff-label or unapproved promotion of medical products2010$422,500,000
Guidant LLCBoston Scientific Corp.medical equipment and suppliesdrug or medical equipment safety violation2011$296,000,000
Elan Corporation PLCPerrigopharmaceuticalsoff-label or unapproved promotion of medical products2010$203,000,000
Endo Health Solutions Inc.Endo Internationalpharmaceuticalsoff-label or unapproved promotion of medical products2014$192,700,000
Forest Pharmaceuticals Inc.AbbViepharmaceuticalsoff-label or unapproved promotion of medical products2011$164,000,000
Warner Chilcott PLCAbbViepharmaceuticalsoff-label or unapproved promotion of medical products2015$125,000,000
Boehringer Ingelheim Pharmaceuticals Inc.Boehringer Ingelheimpharmaceuticalsoff-label or unapproved promotion of medical products2012$95,000,000
Scios Inc.Johnson & Johnsonpharmaceuticalsoff-label or unapproved promotion of medical products2011$85,000,000
Ortho-McNeil Pharmaceutical LLCJohnson & Johnsonpharmaceuticalsoff-label or unapproved promotion of medical products2010$81,000,000
OtisMed Corp.Strykermedical equipment and suppliesdrug or medical equipment safety violation2014$79,560,000
Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals CorporationNovartispharmaceuticalsoff-label or unapproved promotion of medical products2010$72,500,000
Shire Pharmaceuticals LLCTakeda Pharmaceuticalpharmaceuticalsoff-label or unapproved promotion of medical products2014$56,500,000
Pfizer Inc.Pfizerpharmaceuticalsdrug or medical equipment safety violation2012$55,000,000
Par Pharmaceutical Companies Inc.Endo Internationalpharmaceuticalsoff-label or unapproved promotion of medical products2013$45,000,000
Kos PharmaceuticalsAbbViepharmaceuticalskickbacks and bribery2010$41,500,000
CareFusion Corp.Becton Dickinsonmedical equipment and suppliesFalse Claims Act and related2014$40,100,000
InterMune Inc.Rochepharmaceuticalsoff-label or unapproved promotion of medical products2006$36,900,000
Eli Lilly and CompanyEli Lillypharmaceuticalsoff-label or unapproved promotion of medical products2005$36,000,000
UCB Inc.UCBpharmaceuticalsoff-label or unapproved promotion of medical products2011$34,000,000
Genzyme CorporationSanofipharmaceuticalsdrug or medical equipment safety violation2015$32,587,439
Boston Scientific Corp.Boston Scientific Corp.medical equipment and suppliesdrug or medical equipment safety violation2013$30,000,000
Wyeth-Ayerst Laboratories DivisionPfizerpharmaceuticalsdrug or medical equipment safety violation2000$30,000,000
Healthpoint Ltd. and DFB Pharmaceuticals off-label or unapproved promotion of medical products2012$28,000,000
Ethex Corporation drug or medical equipment safety violation2010$27,600,000
McNeil-PPC Inc.Johnson & Johnsonpharmaceuticalsdrug or medical equipment safety violation2015$25,000,000
Novo Nordisk Inc.Novo Holdings A/Spharmaceuticalsoff-label or unapproved promotion of medical products2011$25,000,000
Medtronic Inc.Medtronicmedical equipment and supplieskickbacks and bribery2011$23,500,000
Pfizer Inc.Pfizerpharmaceuticalsoff-label or unapproved promotion of medical products2011$14,500,000
ConAgra Grocery Products LLCConAgra Brandsfood productsfood safety violation2015$11,200,000
Eisai Inc.Eisaipharmaceuticalsoff-label or unapproved promotion of medical products2010$11,000,000
Cell Therapeutics Inc. off-label or unapproved promotion of medical products2007$10,500,000
B. Braun Medical Inc.B. Braun Melsungenmedical equipment and suppliesdrug or medical equipment safety violation2016$7,800,000
Quality Egg LLCQuality Eggfood productsfood safety violation2015$6,790,000
Spectranetics CorporationRoyal Philipsdiversifiedoff-label or unapproved promotion of medical products2009$5,000,000
Otsuka American Pharmaceutical Inc.Otsuka Pharmaceuticalpharmaceuticalsoff-label or unapproved promotion of medical products2008$4,000,000
Atricure Inc.AtriCuremedical equipment and suppliesoff-label or unapproved promotion of medical products2010$3,760,000
Cypress Pharmaceutical Inc.Currax Pharmaceuticalspharmaceuticalsoff-label or unapproved promotion of medical products2012$2,800,000
GNC Holdings Inc.Harbin Pharmaceutical Grouppharmaceuticalsdrug or medical equipment safety violation2016$2,250,000
Advanced Sterilization Products, a division of Ethicon Inc.Johnson & Johnsonpharmaceuticalsdrug or medical equipment safety violation2013$1,200,000
Quality Poultry and Seafood Inc. consumer protection violation2024$1,150,000
SCM True Air Technologies, Inc. drug or medical equipment safety violation2017$711,691
Globus Medical Inc.Globus Medicalmedical equipment and suppliesoff-label or unapproved promotion of medical products2012$550,000
Roos Foods Inc. food safety violation2016$100,000
True World Foods Chicago, LLC environmental violation2008$60,000
(*): Penalty amounts marked by an asterisk are ones announced by more than one agency. Parent penalty totals are adjusted to avoid double-counting.