Ernest Bizjak

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OC OMQ DDQI GCBII

Total Inspections: 72

Total 483s Issued: 54

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 11 days

Shortest Inspection: 1 days

Average Length of Inspection: 0.7 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2015-05-29NIH Clinical Center Pharmacy DepartmentBethesdaUnited States3011547221
2013-02-07Amphastar France PharmaceuticalsEragny Sur EpteFrance3003672088
2013-02-01Coty Lancaster SAMMonacoMonaco1000298299
2012-07-26Barr Laboratories, Inc.ForestUnited States3000718267
2012-02-02Viatris Inc.MorgantownUnited States1110315
2012-01-13Aphena Pharma Solutions-Maryland LLCEastonUnited States1130591
2011-12-12United Therapeutics CorporationSilver SpringUnited States3003368324
2011-11-30Firebird Manufacturing, LLCSouth BostonUnited States3008453106
2011-11-18ChemPacific CorporationBaltimoreUnited States3003299802
2011-11-17ChemPacific CorporationBaltimoreUnited States3003299802

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Co-Inspectors

NameInspectionsLast Inspection
Brooke K Higgins172012
Rachel C Harrington92011
Nebil A Oumer32012
Monique-Rac Lester32010
Merideth K Rose32010
William A Warnick22012
Latoya S Oliver-Powell22010
Stacey A Priest22010
Brian R Yaun22010
Daniel R Azar22009
Patric C Klotzbuecher22009
Thomas J Arista12015
Rabin N Ghoshal12012
Paula J Bretz12012
Sam Pepe12012
Karen E Dorazio12011
Susan S Jaughn12010
Jesse P Hardin12010
Carrie L Doupnik12010
Tania E Vizcaino12010
Lakisha M Williams12009
Hector J Colon-Torres12009
Erin L Mcfiren12009
Joey C West12009
Patsy J Domingo12008
Tina M Pawlowski12008
Rebecca E Dombrowski12008

Active Locations

Year-wise Inspection Count