Overview
- 153 inspections across 151 sites are on record.
- 321 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-04-21.
At a glance
Inspections
153
Sites
151
Observations
321
Career since
Jan 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| American Regent, Inc. | 21 Apr 2026 | Human Drugs | On file |
| SCA Pharmaceuticals, LLC | 13 Mar 2026 | Human Drugs | On file |
| Novo Nordisk US Bio Production Inc. | 9 Dec 2025 | Human Drugs | On file |
| Nephron SC, LLC | 22 Aug 2025 | Human Drugs | On file |
| Hainan Simcere Pharmaceutical Co., Ltd. | 29 Apr 2025 | Human Drugs |
Sites inspected
American Regent, Inc.Shirley, United States1 insp.
SCA Pharmaceuticals, LLCWindsor, United States1 insp.
Novo Nordisk US Bio Production Inc.West Lebanon, United States1 insp.
Nephron SC, LLCWest Columbia, United States1 insp.
Hainan Simcere Pharmaceutical Co., Ltd.Haikou, China1 insp.
Co-investigators
Investigators who share inspections with this person.
Susan M Jackson14 shared
Susanna E Ford10 shared
Anissa M Vargas5 shared
Vivin George4 shared
Alice S Tsao4 shared
Jacqueline M Diaz Albert4 shared
Cynthia Jim4 shared
Katherine Szestypalow4 shared
Felix Maldonado3 shared
Dongping Dai3 shared
Full investigator report
Get the verbatim findings behind Simone E Pitts' 321 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