John Arigo
Division Director at Fda
Based in Silver Spring, United States
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Seniority
Director
Department
Public Administration & Safety
Location
Silver Spring
Industry
Government Administration
Company size
17K
Contact information
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j•••••••@fda.gov
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Background
About John Arigo
Our main area of focus is the review of the sterility assurance and manufacturing aspect of ANDAs, NDAs, INDs and DMFs for sterile pharmaceutical products within the Office of Pharmaceutical Manufacturing Assessment, Food and Drug Administration, Center for Drug Evaluation and Research. We have expertise in container closure integrity validation testing, antimicrobial effectiveness testing, general manufacturing processes and environmental monitoring of aseptic processing lines, sterilization and depyrogenation validation, and conformance to USP and USP finished drug product endotoxin testing and finished drug product sterility testing.
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