Barbara J Breithaupt - FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20705

Organizations: DHHS FDA CDER OMPT CDER OPQ OS DQSA IAB

Overview Statistics

73
Total Inspections
60
Total 483s Issued
5
Warning Letters Issued

Inspection Details

Longest Inspection: 29 days
Shortest Inspection: 1 days
Average Length: 3.0 days

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Barbara J Breithaupt's Recent Inspections

DateCompanyCityCountryFEI Number483
2021-05-21Genentech, Inc.HillsboroUnited States3007232634
2018-09-27Synergy Health Daniken AGDaniken SoSwitzerland3002808269
2015-05-08Montana Compounding Pharmacy P.C.MissoulaUnited States3011412185
2015-04-16PETNET Solutions IncKentUnited States3008203744
2015-03-18Genzyme A Sanofi CompanyLynnwoodUnited States3007934434
2014-11-21Galena Biopharma, Inc.San RamonUnited States3011078156
2014-09-26Fresenius Kabi Deutschland GmbHFriedberg (hessen)Germany3002851530
2014-09-16Sandoz GmbHKundlAustria3002806523
2014-04-15Jubilant HollisterStier LLCSpokaneUnited States3010477
2014-02-14Holopack Verpackungstechnik GmbHSulzbach-LaufenGermany3002808845

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Barbara J Breithaupt - Co-Inspectors

NameInspectionsLast Inspection
Lawrence Y Lee82012
James S Stuart62015
Dandan Wang42013
Maxine H Wong42010
Sarah E Mcmullen42010
Steven A Gonzales32014
Maria P Kelly-Doggett32013
Donald W Jehn32010
Luis M Burgos Medero32010
Diane T Wade22015
Tracy K Li22015
Santos E Camara22014
Robert D Tollefsen22013
Sneha S Patel22012
Katherine Szestypalow22012
Sunitha K Rajaram22011
Peter C Chow22010
Anita Narula22010
Patric C Klotzbuecher22008
Susan T Hadman12018
Margaret M Annes12018
Deborah L Wade12015
Marquessa M Rowe12015
Allison V Bonnenburg12015
Jen-Jen Sui12015
Marijo B Kambere12015
Lynda L Perry12015
Andrew J Idzior12014
Mark W Babbitt12014
Eileen A Liu12014
Omotunde O Osunsanmi12014
Eric L Dong12013
Brenda W Uratani12012
Donald C Obenhuber12012
Bo Chi12012
Michelle Y Clark Stuart12011
Walden H Lee12011
Marci M Deleon12010
Don A Brunssen12010
Randy L Self12009
Heika R Tait12009
S. L Brown12009
Caryn M Mcnab12009
Marilyn M White12008

Barbara J Breithaupt's Active Locations

  • United States
  • Netherlands
  • Germany
  • Switzerland
  • Canada
  • Ireland
  • Poland
  • India
  • China
  • Taiwan
  • Austria
  • Sweden

Barbara J Breithaupt's Year-wise Inspection Count

  • 2008:10 inspections
  • 2009:12 inspections
  • 2010:11 inspections
  • 2011:10 inspections
  • 2012:11 inspections
  • 2013:7 inspections
  • 2014:7 inspections
  • 2015:3 inspections
  • 2018:1 inspections
  • 2021:1 inspections
Last Updated: 2025-05-14 06:11:22