FDA Investigator

Mindy M Chou

Latest inspection on record: Grand Island, United States, May 2026 · records back to 2014

Human DrugsAnimal Drugs & FeedsFoods & CosmeticsBiologicsMedical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

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.

SiteDateCategoryForm 483
Fresenius Kabi USA, LLC14 May 2026Human DrugsOn file
Professional Disposables International, Inc.31 Mar 2026Human DrugsOn file
ONY Biotech, Inc.5 Feb 2026Human DrugsOn file
US Specialty Formulations LLC14 Jan 2026Human DrugsOn file
Chartwell Pharmaceuticals Congers, LLC18 Nov 2025Human DrugsView 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
Natasha Gupta3 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

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