FDA Investigator Andrew Byrnes, PhD
Andrew Byrnes, PhD has conducted inspections on 5 sites in 2 countries as of 15 Jun 2020. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
5
Last Inspection Date:
15 Jun 2020
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America,
United Kingdom of Great Britain and Northern Ireland
FDA Investigators that have inspected at least one site in common with Andrew Byrnes, PhD:
Angela S Whatley,
Bo Liang, PhD,
Burnell M Henry,
Christine A Harman, PhD,
Claire M Minden,
Deborah M Trout,
Eileen A Liu,
Emmanuel Adu Gyamfi, PhD,
Grace I Cortesini,
Jacqueline Mdiaz Albertini,
Kevin J Matthews,
LCDR Debra Emerson,
Lewis K Antwi,
Linda Thai,
Mihaly S Ligmond,
Prabhu P Raju,
Pratik S Upadhyay, DDC,
Priscilla M Pastrana,
Scott T Ballard,
Steven E Bowen, PhD,
Sukyoung Sohn,
Thai D Truong,
Viviana R Ramirez,
Wanda E Pagan, PhD,
Wei Wang, PhD
Andrew Byrnes, PhD's Documents
Publish Date | Document Type | Title |
---|---|---|
February, 2019 | FDA 483 Response | Novartis Gene Therapies, Inc. - Form 483R, 2019-03-12 |
June, 2020 | FDA 483 | Catalent Maryland, Inc. - Form 483, 2020-06-19 |
February, 2019 | EIR | Novartis Gene Therapies, Inc. - EIR, 2019-02-15 |
February, 2018 | FDA 483 | Symbiosis Pharmaceutical Services Limited - Form 483, 2018-02-23 |
February, 2019 | FDA 483 | Novartis Gene Therapies, Inc. - Form 483, 2019-02-08 |
February, 2019 | EIR | Novartis Gene Therapies, Inc. - EIR, 2019-02-15 |
June, 2020 | FDA 483 Response | Catalent Maryland, Inc. - Form 483R, 2020-07-13 |
Experience Redica Systems’ NEW investigator profiles and dashboards
Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:
- Total inspections conducted
- 483 rate
- OAI rate
- Warning Letter rate
- Inspections by Industry, Scope, and Inspection Reason
- And much more
Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.
![FDA Investigator Profile Icon](/images/InspectorProfile.png)
Talk to sales to access our investigator profiles
Loading...
Investigator Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:
Inspection Intelligence
- Pre-Approval Inspection (PAI) trends
- The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
- Latest 483s: see what the trends are across all FDA Investigators
- CFR Heatmap: Citations aggregated by Subpart by Year
Vendor Intelligence
- Full inspection histories for your vendors down to the specific site level
- All of the functionality mentioned above but isolated to just your vendors
Regulatory Intelligence
- Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
- All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more