Overview
- 28 inspections across 28 sites are on record.
- 12 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2020-03-06.
At a glance
Inspections
28
Sites
28
Observations
12
Career since
Jan 2017
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Kyowa Kirin Pharmaceutical Research, Inc. | 6 Mar 2020 | Human Drugs | On file |
| Lambda Therapeutic Research Ltd. | 24 Jan 2020 | Human Drugs | On file |
| Zenith Technology Corporation, Ltd. | 16 Jan 2020 | Human Drugs | |
| Panexcell Clinical Lab PVT. LTD. | 22 Nov 2019 | Human Drugs | |
| Cohance Lifesciences Limited | 15 Nov 2019 | Human Drugs |
Sites inspected
Kyowa Kirin Pharmaceutical Research, Inc.La Jolla, United States1 insp.
Lambda Therapeutic Research Ltd.Ahmedabad, India1 insp.
Zenith Technology Corporation, Ltd.Dunedin, New Zealand1 insp.
Panexcell Clinical Lab PVT. LTD.Navi Mumbai, India1 insp.
Cohance Lifesciences LimitedHyderabad, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Li-Hong Yeh4 shared
Kara A Scheibner4 shared
Melkamu Getie Kebtie3 shared
Sripal R Mada3 shared
Makini Cobourne-Duval2 shared
Gajendiran Mahadevan2 shared
Hasan A Irier2 shared
Gopa Biswas2 shared
Sherri N Rohlf1 shared
Lori Gioia1 shared
Full investigator report
Get the verbatim findings behind Amanda Lewin's 12 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