Overview
- 27 inspections across 24 sites are on record.
- 75 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2023-01-20.
At a glance
Inspections
27
Sites
24
Observations
75
Career since
Jul 2018
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| SOFIE Co. dba Sofie | 20 Jan 2023 | Human Drugs | On file |
| Quinta-Analytica s.r.o. - Provozovna Brno | 23 Nov 2022 | Human Drugs | |
| Lek d.d. | 18 Nov 2022 | Human Drugs | |
| Cambrex Profarmaco Milano Srl | 11 Nov 2022 | Human Drugs | |
| Pfizer, Inc. | 28 Sep 2022 | Human Drugs |
Sites inspected
SOFIE Co. dba SofieSomerset, United States1 insp.
Quinta-Analytica s.r.o. - Provozovna BrnoBrno-Reckovice A Mokra Hora, Czech Republic1 insp.
Lek d.d.Ljubljana, Slovenia1 insp.
Cambrex Profarmaco Milano SrlPaullo, Italy1 insp.
Pfizer, Inc.Parsippany, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Yvesna C Blaise4 shared
Anthony J Donato3 shared
Guerlain Ulysse2 shared
Robin P Mathew2 shared
Amit Kokate2 shared
Mesfin Abdi2 shared
Josh Renzo N Ramilo1 shared
Victoria Spivak1 shared
Odera I Ekwunife1 shared
Saleem A Akhtar1 shared
Full investigator report
Get the verbatim findings behind Monika Borkowska's 75 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