Violation Tracker Agency Summary Page

Agency Name: 
Food and Drug Administration
Penalty Total since 2000: 
$19,482,069,130
Number of Records: 
58
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 Parent CompaniesTotal Penalty $Number of Records
GlaxoSmithKline$3,750,000,0002
Pfizer$3,290,400,0005
Johnson & Johnson$2,392,200,0005
Abbott Laboratories$1,500,000,0001
Eli Lilly$1,451,000,0002
Merck$950,000,0001
Allergan$889,000,0003
Amgen$762,000,0001
Merck KGaA (EMD)$704,000,0001
AstraZeneca$520,000,0001


Individual Penalty Records:

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Company Parent Parent Major Industry Primary Offense Type Year Penalty Amountsort icon
GlaxoSmithKline LLC GlaxoSmithKline pharmaceuticals off-label or unapproved promotion of medical products 2012 $3,000,000,000
Pfizer Inc. Pfizer pharmaceuticals off-label or unapproved promotion of medical products 2009 $2,300,000,000
Johnson & Johnson Johnson & Johnson pharmaceuticals off-label or unapproved promotion of medical products 2013 $2,200,000,000
Abbott Laboratories Inc. Abbott Laboratories pharmaceuticals off-label or unapproved promotion of medical products 2012 $1,500,000,000
Eli Lilly and Company Eli Lilly pharmaceuticals off-label or unapproved promotion of medical products 2009 $1,415,000,000
Merck, Sharp & Dohme Merck pharmaceuticals off-label or unapproved promotion of medical products 2011 $950,000,000
Amgen Inc. Amgen pharmaceuticals off-label or unapproved promotion of medical products 2012 $762,000,000
SB Pharmco Puerto Rico Inc. GlaxoSmithKline pharmaceuticals drug or medical equipment safety violation 2010 $750,000,000
Serono, S.A. Merck KGaA (EMD) pharmaceuticals off-label or unapproved promotion of medical products 2005 $704,000,000
Allergan Inc. Allergan pharmaceuticals off-label or unapproved promotion of medical products 2010 $600,000,000
AstraZeneca LP AstraZeneca pharmaceuticals off-label or unapproved promotion of medical products 2010 $520,000,000
Ranbaxy USA Inc. Sun Pharmaceuticals pharmaceuticals drug or medical equipment safety violation 2013 $500,000,000
Google Inc. Alphabet Inc. information technology off-label or unapproved promotion of medical products 2011 $500,000,000
Wyeth Pharmaceuticals Inc. Pfizer pharmaceuticals off-label or unapproved promotion of medical products 2013 $490,900,000
Warner-Lambert Pfizer pharmaceuticals off-label or unapproved promotion of medical products 2004 $430,000,000
Cephalon Inc Teva Pharmaceutical Industries pharmaceuticals off-label or unapproved promotion of medical products 2008 $425,000,000
Novartis Pharmaceuticals Corporation Novartis pharmaceuticals off-label or unapproved promotion of medical products 2010 $422,500,000
Guidant LLC Boston Scientific medical equipment and supplies drug or medical equipment safety violation 2011 $296,000,000
Elan Corporation PLC Perrigo pharmaceuticals off-label or unapproved promotion of medical products 2010 $203,000,000
Endo Health Solutions Inc. Endo International pharmaceuticals off-label or unapproved promotion of medical products 2014 $192,700,000
Forest Pharmaceuticals Inc. Allergan pharmaceuticals off-label or unapproved promotion of medical products 2011 $164,000,000
Warner Chilcott PLC Allergan pharmaceuticals off-label or unapproved promotion of medical products 2015 $125,000,000
Boehringer Ingelheim Pharmaceuticals Inc. Boehringer Ingelheim pharmaceuticals off-label or unapproved promotion of medical products 2012 $95,000,000
Scios Inc. Johnson & Johnson pharmaceuticals off-label or unapproved promotion of medical products 2011 $85,000,000
Ortho-McNeil Pharmaceutical LLC Johnson & Johnson pharmaceuticals off-label or unapproved promotion of medical products 2010 $81,000,000
OtisMed Corp. Stryker medical equipment and supplies drug or medical equipment safety violation 2014 $79,560,000
Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation Novartis pharmaceuticals off-label or unapproved promotion of medical products 2010 $72,500,000
Shire Pharmaceuticals LLC Shire pharmaceuticals off-label or unapproved promotion of medical products 2014 $56,500,000
Pfizer Inc. Pfizer pharmaceuticals drug or medical equipment safety violation 2012 $55,000,000
Par Pharmaceutical Companies Inc. Endo International pharmaceuticals off-label or unapproved promotion of medical products 2013 $45,000,000
Kos Pharmaceuticals AbbVie pharmaceuticals kickbacks and bribery 2010 $41,500,000
CareFusion Corp. Becton Dickinson medical equipment and supplies False Claims Act 2014 $40,100,000
InterMune Inc.   off-label or unapproved promotion of medical products 2006 $36,900,000
Eli Lilly and Company Eli Lilly pharmaceuticals off-label or unapproved promotion of medical products 2005 $36,000,000
UCB Inc. UCB pharmaceuticals off-label or unapproved promotion of medical products 2011 $34,000,000
Genzyme Corporation Sanofi pharmaceuticals drug or medical equipment safety violation 2015 $32,587,439
Boston Scientific Corp. Boston Scientific medical equipment and supplies drug or medical equipment safety violation 2013 $30,000,000
Healthpoint Ltd. and DFB Pharmaceuticals   off-label or unapproved promotion of medical products 2012 $28,000,000
Ethex Corporation KV Pharmaceutical pharmaceuticals drug or medical equipment safety violation 2010 $27,600,000
McNeil-PPC Inc. Johnson & Johnson pharmaceuticals drug or medical equipment safety violation 2015 $25,000,000
Novo Nordisk Inc. Novo A/S pharmaceuticals off-label or unapproved promotion of medical products 2011 $25,000,000
Medtronic Inc. Medtronic medical equipment and supplies kickbacks and bribery 2011 $23,500,000
Pfizer Inc. Pfizer pharmaceuticals off-label or unapproved promotion of medical products 2011 $14,500,000
ConAgra Grocery Products LLC ConAgra Brands food products food safety violation 2015 $11,200,000
Eisai Inc. Eisai pharmaceuticals off-label or unapproved promotion of medical products 2010 $11,000,000
Cell Therapeutics Inc.   off-label or unapproved promotion of medical products 2007 $10,500,000
B. Braun Medical Inc. B. Braun Melsungen medical equipment and supplies drug or medical equipment safety violation 2016 $7,800,000
Quality Egg LLC Quality Egg food products food safety violation 2015 $6,790,000
Spectranetics Corporation Royal Philips diversified off-label or unapproved promotion of medical products 2009 $5,000,000
Otsuka American Pharmaceutical Inc. Otsuka Pharmaceutical pharmaceuticals off-label or unapproved promotion of medical products 2008 $4,000,000
Atricure Inc. AtriCure medical equipment and supplies off-label or unapproved promotion of medical products 2010 $3,760,000
Cypress Pharmaceutical Inc. Pernix Therapeutics pharmaceuticals off-label or unapproved promotion of medical products 2012 $2,800,000
GNC Holdings Inc. GNC Holdings retailing drug or medical equipment safety violation 2016 $2,250,000
Advanced Sterilization Products, a division of Ethicon Inc. Johnson & Johnson pharmaceuticals drug or medical equipment safety violation 2013 $1,200,000
SCM True Air Technologies, Inc.   drug or medical equipment safety violation 2017 $711,691
Globus Medical Inc. Globus Medical medical equipment and supplies off-label or unapproved promotion of medical products 2012 $550,000
Roos Foods Inc.   food safety violation 2016 $100,000
True World Foods Chicago, LLC   environmental violation 2008 $60,000
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