Overview
- 26 inspections across 25 sites are on record.
- 28 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2018-07-26.
At a glance
Inspections
26
Sites
25
Observations
28
Career since
Jun 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Coherus Oncology, Inc. | 26 Jul 2018 | Human Drugs | |
| Sandoz GmbH | 2 Mar 2018 | Human Drugs | On file |
| Hospira Zagreb D.O.O. | 20 Feb 2018 | Human Drugs | On file |
| TOYOBO CO., LTD. | 23 Jan 2018 | Human Drugs | On file |
| Shalon Chemical Industries Ltd. | 20 Nov 2017 | Medical Devices & Rad Health | View 483 → |
Sites inspected
Coherus Oncology, Inc.Camarillo, United States1 insp.
Sandoz GmbHLangkampfen, Austria1 insp.
Hospira Zagreb D.O.O.Brdovec, Croatia1 insp.
TOYOBO CO., LTD.Otsu, Japan1 insp.
Shalon Chemical Industries Ltd.Kiryat Gat, Israel1 insp.
Co-investigators
Investigators who share inspections with this person.
Joseph D Doleski3 shared
Jose O Hernandez2 shared
Joyce A Rockwell2 shared
Nawab A Siddiqui2 shared
Maxwell L Van Tassell1 shared
Reyes Candau-Chacon1 shared
Michael Shanks1 shared
Steven Fong1 shared
Zhong Li1 shared
Ephrem T Hunde1 shared
Full investigator report
Get the verbatim findings behind Marion Michaelis' 28 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