Overview
- 65 inspections across 55 sites are on record.
- 79 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2013-03-13.
At a glance
Inspections
65
Sites
55
Observations
79
Career since
Mar 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | 13 Mar 2013 | Medical Devices & Rad Health | |
| Isomedix Operations Inc. | 16 Jan 2013 | ||
| Majestic Drug Co Inc | 29 Nov 2012 | ||
| Roche Diagnostics GmbH | 27 Sep 2012 | ||
| Roche Diagnostics GmbH | 20 Sep 2012 |
Sites inspected
Siemens Healthcare Diagnostics, Inc.Tarrytown, United States1 insp.
Isomedix Operations Inc.Chester, United States1 insp.
Majestic Drug Co IncSouth Fallsburg, United States1 insp.
Roche Diagnostics GmbHMannheim, Germany1 insp.
Roche Diagnostics GmbHPenzberg, Germany1 insp.
Co-investigators
Investigators who share inspections with this person.
Carolyn J Cook2 shared
Kimberley A Ricketts1 shared
Shreya Shah1 shared
Jacqueline S Warner1 shared
Catherine M Beer1 shared
William M Rennells1 shared
Chad N Thompson1 shared
Dipesh K Shah1 shared
Full investigator report
Get the verbatim findings behind Paul E Stein's 79 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