FDA Investigator Ashley J Burns
Ashley J Burns has inspections in 3 countries as of 29 Sep 2023. Ashley J Burns has collaborated with a combined 820 experts on various inspections, contributing to compliance and improvement across diverse sectors.
Investigator Details
Number of Inspected Sites:
5
Last Inspection Date:
29 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America,
Denmark,
United Kingdom of Great Britain and Northern Ireland
Co-Investigator(s):
Ann Marie Montemurro,
Colleen F Hoyt,
Cynthia Jim, CSO,
Denis Gavin, PhD,
Dennis Cantellops Paite,
Elias N Paz Alonzo,
Frank J Marciniak,
Frederick Razzaghi,
Gayle S Lawson,
Gene D Arcy,
Harperd,
Helen B Ricalde,
Jacqueline Mdiaz Albertini,
James L Dunnie, Jr,
James R Birkenstamm,
Joan Johnson,
Joanne E King,
Jose Acruz Gonzalez,
Joy Rkozlowski Klena,
Kent A Conforti,
Kimberly L Schultz,
LCDR Debra Emerson,
Linda M Hoover,
Lydia Irosas Marty,
Mayar M Mussa,
Meihong Liu,
Michael Serrano,
Mihaela Jason,
Mikhail V Ovanesov, PhD,
Pankaj H Amin,
Paul L Bellamy,
Paula A Trost,
Prabhu P Raju,
Priscilla M Pastrana,
Ramon E Martinez,
Randa Melhem, PhD,
Richard T Riggie,
Simone E Pitts,
Stephen D Eich,
Susan M Jackson,
Thai D Truong,
Thai Truong,
Unnee Ranjan,
Vlada Matusovsky,
Xiaobin Lu (Victor), PhD,
Yumi J Hiramine
Ashley J Burns's Documents
Publish Date | Document Type | Title |
---|---|---|
April, 2017 | EIR | Novartis Pharmaceuticals Corporation - EIR, 2017-04-07 |
September, 2023 | FDA 483 | Teva Pharmaceuticals USA, Inc - Form 483, 2023-09-29 |
April, 2017 | FDA 483 Response | Novartis Pharmaceuticals Corporation - Form 483R, 2017-04-21 |
April, 2017 | FDA 483 | Novartis Pharmaceuticals Corporation - Form 483, 2017-04-07 |
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](https://redica.com/document-store/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