Omotunde O Osunsanmi

FDA Investigator Report

Designation: CSO(BIOLOGICS)

Duty Station: Irvine CA 92612

Organizations: DHHS FDA ORA OGROP ORA OMPTO OBPO BPIS

Total Inspections: 125

Total 483s Issued: 121

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 23 days

Shortest Inspection: 1 days

Average Length of Inspection: 5.5 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2022-04-07Baxalta US Inc.Thousand OaksUnited States1000519965
2022-03-02National Genetics InstituteLos AngelesUnited States3003082450
2020-03-06Broekman InstituteSomerenNetherlands3009390218
2020-03-04BioConnection B.V.OssNetherlands3011445650
2020-02-13LONZA HAYWARDHaywardUnited States3014003000
2020-01-17Baxalta US Inc.Thousand OaksUnited States1000519965
2019-11-08Dendreon Pharmaceuticals LLCSeal BeachUnited States3008821247
2019-09-12Grifols Biologicals LLCCity Of IndustryUnited States2077802
2019-09-12Grifols Biologicals LLCLos AngelesUnited States2080769
2019-06-06GlaxoSmithKline Vaccines SrlSovicilleItaly3006738517

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Co-Inspectors

NameInspectionsLast Inspection
Mihaly S Ligmond122018
Burnell M Henry112018
Christian Lynch72013
Rose M Ashley62009
Susan M Jackson52016
Cynthia Jim52012
Gene D Arcy42018
Vijaya L Simhadri32019
Lewis K Antwi22022
Eileen A Liu22020
Nobuko H Katagiri22019
Olga Simakova22019
Marian Major22019
Darla J Christopher22019
Decarlos A Gomez22019
Simone E Pitts22015
Debra M Emerson22014
Linda Thai12022
Svetlana A Shestopal12020
Natalya M Ananyeva12020
Malgorzata G Norton12019
Silvia Wanis12018
Yonggang Wang12018
Lily Y Koo12018
Michael C Kennedy12018
Chava Kimchi Sarfaty12018
Aikaterini Alexaki12018
Deborah M Trout12018
Elmina E Akwo12018
Abby L Mozeke-Baker12018
Leslie D Wagner12017
Christian J Sauder12017
Craig D Zagata12017
Arie Menachem12017
Lestine C Webb12017
Carrie A Hughes12017
Michele L Forster12015
Barbara J Breithaupt12014
Andrew J Idzior12014
Mark W Babbitt12014
Margaret Torres-Vazquez12013
Jennifer Macmillan12012
Parul M Patel12012
Melissa J Holz12010
Helen B Ricalde12010
Tracy J Washington12009

Active Locations

Year-wise Inspection Count