Overview
- 3 inspections across 3 sites are on record.
- 3 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2017-09-29.
At a glance
Inspections
3
Sites
3
Observations
3
Career since
Jun 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Unimark Remedies Limited | 29 Sep 2017 | Human Drugs | On file |
| Divi's Laboratories Limited | 19 Sep 2017 | Human Drugs | On file |
| Apotex Pharmachem India Pvt. Ltd. | 3 Jun 2016 | Human Drugs | On file |
Sites inspected
Unimark Remedies LimitedPardi, India1 insp.
Divi's Laboratories LimitedVisakhapatnam District, India1 insp.
Apotex Pharmachem India Pvt. Ltd.Bangalore, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Erika V Butler2 shared
Virgilio F Pacio1 shared
Full investigator report
Get the verbatim findings behind Tsedenia Woldehanna's 3 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site