FDA Investigator

Stephenie M Ortiz

Latest inspection on record: Edison, United States, March 2026 · records back to 2023

Human Drugs

FDA inspection record · Last updated July 12, 2026

Overview

  • 24 inspections across 20 sites are on record.
  • 64 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-03-27.

At a glance

Inspections

24

Sites

20

Observations

64

Career since

Sep 2023

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Bentley Laboratories LLC27 Mar 2026Human DrugsOn file
New Life Pharma LLC13 Feb 2026Human DrugsView 483 →
Health Pharma USA LLC18 Nov 2025Human DrugsView 483 →
Molecular PharmaGroup LLC11 Aug 2025Human DrugsView 483 →
Pharmaron Manufacturing Services (US) LLC17 Jul 2025Human Drugs

Sites inspected

Bentley Laboratories LLCEdison, United States1 insp.
New Life Pharma LLCNorthvale, United States1 insp.
Health Pharma USA LLCRahway, United States1 insp.
Molecular PharmaGroup LLCNew Providence, United States1 insp.
Pharmaron Manufacturing Services (US) LLCCoventry, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Suchan Kim5 shared
Jenny Sung3 shared
Yaharn Su2 shared

Full investigator report

Get the verbatim findings behind Stephenie M Ortiz's 64 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