FDA Investigator Tsedenia Woldehanna

Tsedenia Woldehanna has conducted inspections on 4 sites in 2 countries as of 21 Sep 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
4
Last Inspection Date:
21 Sep 2017
Investigator Role:
FDA Investigator
Redica ID:
100007460
Countries of Inspections:
India, United States of America
FDA Investigators that have inspected at least one site in common with Tsedenia Woldehanna:
Adam R Cooke, Ademola O Daramola, Bonita S Chester, CDR Rochelle B Young, RPh, MSA, CDR Thomas R Berry, PPh, Christopher S Keating, Daniel J Roberts, Dennis Cantellops Paite, Devaughn Edwards, Dipesh K Shah, Dr. Robert C Horan, MD, Erika V Butler, Felix Maldonado, Hai Lient Phung, Jason F Chancey, Katherine Szestypalow, Kathleen D Culver, Latorie S Jones, Leo J Lagrotte, Liming Zhang, Marcellinus D Dordunoo, Marie F Morin, Massoud Motamed, Michael A Charles, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Patrice S Hall, Penny H Mccarver, Peter E Baker, Pratik S Upadhyay, DDC, Regina T Brown, Seneca D Toms, Sonya M Edmonds, Stephen D Eich, Tamil Arasu, PhD, Tawny L Colling, Teresa I Navas, Tricia S Martinez, Virgilio F Pacio, CSO, Walden H Lee

Tsedenia Woldehanna's Documents

Publish Date Document Type Title
September, 2013 FDA 483 Eisai Inc - Form 483, 2013-09-13
September, 2017 EIR DIVI'S LABORATORIES LIMITED - EIR, 2017-09-19
June, 2016 FDA 483 Apotex Pharmachem India Pvt. Ltd. - Form 483, 2016-06-03
September, 2017 FDA 483 DIVI'S LABORATORIES LIMITED - Form 483, 2017-09-19

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

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