FDA Investigator Edward M James
Edward M James has conducted inspections on 45 sites in 1 countries as of 09 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
45
Last Inspection Date:
09 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Edward M James:
Alfred P Pistorio,
Amy L Mcintyre,
Anthony J Ladner,
April L Young,
Artem Melnik,
Bradley A Servais,
Carolyn A Warren,
Christina A Castineyra,
Christine M Erickson,
Courtney R Ingalsbe,
Courtney R Tiegs,
Dacia E Quick,
Dale A Nyberg,
Darren D Holaday,
David B Wieneke,
Debra D Devlieger,
Diane T Reindl,
Dianna C Sonnenburg,
Douglas J Snyder,
Edward A Fabiano,
Elizabeth P Mayer,
Ellen C Weisensel,
Emily E Markgraf,
Fallon J Ryan,
Fannie M Harrell,
Frank S Sedzielarz,
Garrett W Steiner,
Gina M Scholze,
Grant M Ruis,
Gregory W Smith,
Heather Akleimola Hulbert,
Ivan E Reyes,
Jake T Lane,
James K Ireland,
Janis R Armedoriz,
Jeffery A Hangartner,
Jennifer A Longie Vollom,
Jennifer R Mathern,
Jeremy L Tri,
Jesse P Romenesko,
Jessica M Novak,
John E Emmert,
Julie Woodberry,
Karen M Labounty,
Karla J Youngberg,
Kellie L Thommes, RN,
Kellie L Westerbuhr,
Kenneth A Libertoski,
Kibily D Dembele,
Krista K Petersen,
Kyle J Mccracken,
Larae M Koopman,
Lauren E Merz,
Lauren E Sanger,
Linda V Weyer,
Mada A Tautges,
Madeline T Campbell,
Margaret M Lubbers Solberg,
Maria E Treadwell,
Marie A Fadden,
Melissa D Kalik,
Melissa I Michurski,
Michael E Cimaglio,
Mohammed H Adam,
Paola E Lathrop,
Patricia A Holmstrom,
Patrick J Campbell,
Peter T Erlandson,
Rebecca L Caulfield,
Rebecca L Keller,
Robert H Claflin,
Robert J Waldorf,
Ross J Grigsby,
Ryan J Benedict,
Sana A Elassar,
Sandra A Hughes,
Sandra Sejdinovic,
Scott A Golladay,
Sharon M Harold,
Shaun M Olson,
Steven A Skaar,
Tenzin Jangchup,
Theresa C Klaman,
Traci C Kelm,
Troy A Brenny,
Victoria L Palmer,
Wayne W Grundstrom,
Wendy L Trefethren Grang,
Yehualashet A Gessesse,
Zachary P Wachlarowicz
Edward M James's Documents
Publish Date | Document Type | Title |
---|---|---|
April, 2017 | FDA 483 | Pride Dairy, Inc. - Form 483, 2017-04-27 |
April, 2015 | FDA 483 | Nutri-Dyn Midwest, Inc. - Form 483, 2015-04-10 |
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