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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Schedule a DemoRecent Inspections
Date | Company | City | Country | FEI Number | 483 |
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2024-11-15 | Catalent Maryland Inc | Harmans | United States | 3015434301 | |
2024-08-23 | Nova Laboratories Ltd | Wigston | United Kingdom | 3000323524 | |
2024-08-13 | Protherics UK Limited | Llandysul | United Kingdom | 3001417487 | |
2024-06-07 | PCAS Finland Oy | Turku | Finland | 3003469991 | |
2024-05-28 | FinVector Oy | Kuopio | Finland | 3010227150 | |
2024-05-03 | Grifols Biologicals LLC | Los Angeles | United States | 2080769 | |
2024-03-15 | MedImmune U.K. Limited | Liverpool | United Kingdom | 3004066112 | |
2024-03-05 | Valneva Scotland Ltd. | Livingston | United Kingdom | 3005315117 | |
2024-01-31 | Allermed Laboratories, LLC | San Diego | United States | 1000098920 | |
2023-12-05 | Avioq, Inc. | Durham | United States | 3008376326 | |
Co-Inspectors
Active Locations
- United States
- United Kingdom
- India
- Germany
- Switzerland
- France
- Belgium
- Ireland
- Spain
- Finland
- Australia
- Canada
Year-wise Inspection Count
- 2008: 16 inspections
- 2009: 20 inspections
- 2010: 16 inspections
- 2011: 24 inspections
- 2012: 21 inspections
- 2013: 22 inspections
- 2014: 21 inspections
- 2015: 10 inspections
- 2016: 10 inspections
- 2017: 9 inspections
- 2018: 12 inspections
- 2019: 8 inspections
- 2020: 2 inspections
- 2021: 6 inspections
- 2022: 7 inspections
- 2023: 9 inspections
- 2024: 9 inspections