Gene D Arcy

FDA Investigator Report

Designation: CSO(BIOLOGICS)

Duty Station: Irvine CA 92612

Organizations: DHHS FDA ORA OGROP ORA OMPTO OBPO BPIS

Total Inspections: 222

Total 483s Issued: 117

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 38 days

Shortest Inspection: 1 days

Average Length of Inspection: 4.8 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-11-15Catalent Maryland IncHarmansUnited States3015434301
2024-08-23Nova Laboratories LtdWigstonUnited Kingdom3000323524
2024-08-13Protherics UK LimitedLlandysulUnited Kingdom3001417487
2024-06-07PCAS Finland OyTurkuFinland3003469991
2024-05-28FinVector OyKuopioFinland3010227150
2024-05-03Grifols Biologicals LLCLos AngelesUnited States2080769
2024-03-15MedImmune U.K. LimitedLiverpoolUnited Kingdom3004066112
2024-03-05Valneva Scotland Ltd.LivingstonUnited Kingdom3005315117
2024-01-31Allermed Laboratories, LLCSan DiegoUnited States1000098920
2023-12-05Avioq, Inc.DurhamUnited States3008376326

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Download 483s and EIRs for Gene D Arcy

Co-Inspectors

NameInspectionsLast Inspection
Linda Thai72022
Mihaly S Ligmond72017
Laurel A Beer62023
Scott T Ballard62021
Brentley S Collins52024
Meihong Liu52023
Lewis K Antwi42024
Omotunde O Osunsanmi42018
Ka L Wong42014
Arsen Karapetyan42013
Ana Djurdjevic42013
Shaquenta Y Perkins42013
Brentley S Pittman32024
Peng Zhou32024
Priscilla M Pastrana32024
Creighton T Tuzon32023
Susan M Jackson32022
Cynthia Jim32018
Debra M Emerson32015
Terrance L Thomas32011
Joan A Loreng32009
Anissa M Cheung22024
Elias N Paz Alonzo22023
Nancy L Neiger22023
Richard T Riggie22023
Lauren M Lilly22022
Prajakta A Varadkar22021
Dino A Feigelstock22020
Richard H Coats22019
Sharmila Shrestha22018
Jacqueline M Diaz Albert22018
Uros V Djekic22016
Prabhu P Raju22016
Vashti E Bocker22013
Trushani T Desai22012
Andy B Lee22010
Sean P Desbrow22009
Swati Verma12024
Shafiq Ahadi12024
Edward A Brunt12023
Jacob G Lutz12023
Latorie S Jones12023
Michele Perry-Williams12023
Kimberly M Bigler12022
Pankaj H Amin12021
Lisa M Parsons12020
John F Cipollo12020
Nimmy Mathews12020
Steven E Bowen12019
Susan A Zullo12019
Yonggang Wang12019
Kathleen B Swat12019
Hyesuk Kong12018
James L Kenney12018
Chava Kimchi Sarfaty12018
Aikaterini Alexaki12018
Cody D Rickman12018
Simone E Pitts12018
Ivan E Reyes12018
Leslie D Wagner12017
Christian J Sauder12017
Annette A Ragosta12017
Steven A Rubin12017
Arie Menachem12017
Guang Gao12017
Toyin B Oladimeji12015
Yasamin Ameri12015
David Hwang12014
Randy L Elsberry12014
Tawny L Colling12014
Kimberly M Lichter12014
Ademola O Daramola12013
Lakecha N Lewis12013
Mark E Chan12013
Jocelyn E Massey12012
Yvonne C Wilkes12012
Comyar Shoghi12011
Thao T Kwan12009
Karen L Bauer12009
Joey V Quitania12009
Lawrence H Howell12008
Steven E Porter12008
Michael Araneta12008
Raymond W Brullo12008
Kirtida Patel12008

Active Locations

Year-wise Inspection Count