Overview
- 120 inspections across 104 sites are on record.
- 533 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-14.
At a glance
Inspections
120
Sites
104
Observations
533
Career since
Jun 2014
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Fresenius Kabi USA, LLC | 14 May 2026 | Human Drugs | View 483 → |
| Professional Disposables International, Inc. | 31 Mar 2026 | Human Drugs | View 483 → |
| ONY Biotech, Inc. | 5 Feb 2026 | Human Drugs | View 483 → |
| US Specialty Formulations LLC | 14 Jan 2026 | Human Drugs | View 483 → |
| Chartwell Pharmaceuticals Congers, LLC | 18 Nov 2025 | Human Drugs | View 483 → |
Sites inspected
Fresenius Kabi USA, LLCGrand Island, United States1 insp.
Professional Disposables International, Inc.Orangeburg, United States1 insp.
ONY Biotech, Inc.Amherst, United States1 insp.
US Specialty Formulations LLCAllentown, United States1 insp.
Chartwell Pharmaceuticals Congers, LLCCongers, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Sony Mathews11 shared
Alice S Tsao10 shared
Helen B Ricalde5 shared
Robert C Horan4 shared
Gam S Zamil3 shared
Brandy N Lepage3 shared
Natasha Gupta3 shared
Philip F Istafanos3 shared
Rachael A Moliver3 shared
Lauren H Augustyniak2 shared
Full investigator report
Get the verbatim findings behind Mindy M Chou's 533 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