Overview
- 28 inspections across 26 sites are on record.
- 13 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2018-12-21.
At a glance
Inspections
28
Sites
26
Observations
13
Career since
Jan 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Analys Lab Private Limited | 21 Dec 2018 | Human Drugs | View 483 → |
| GlySens Incorporated | 29 Mar 2018 | Medical Devices & Rad Health | |
| William D Koltun, MD | 30 Jan 2017 | Human Drugs | |
| Patricia Wu, M.D. | 26 Jul 2016 | Human Drugs | |
| Tarek I Hassanein MD | 22 Jun 2016 | Medical Devices & Rad Health |
Sites inspected
Analys Lab Private LimitedSecunderabad, India1 insp.
GlySens IncorporatedSan Diego, United States1 insp.
William D Koltun, MDSan Diego, United States1 insp.
Patricia Wu, M.D.Bonita, United States1 insp.
Tarek I Hassanein MDCoronado, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Sonya L Karsik5 shared
Steven E Porter2 shared
Bapu R Gaddam1 shared
Darren S Brown1 shared
Sparky L Bartee1 shared
Comyar Shoghi1 shared
William S Vitale1 shared
Cntrctmntr Saale1 shared
Brian P Putz1 shared
Virgilio F Pacio1 shared
Full investigator report
Get the verbatim findings behind Mark C Saale's 13 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