FDA Investigator

James R Montero

Latest inspection on record: Xiamen, China, April 2026 · records back to 2009

Medical Devices & Rad HealthFoods & CosmeticsHuman Drugs

FDA inspection record · Last updated July 12, 2026

Overview

  • 261 inspections across 211 sites are on record.
  • 1327 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-04-01.

At a glance

Inspections

261

Sites

211

Observations

1,327

Career since

Mar 2009

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Xiamen Compower Medical Tech Co., Ltd.1 Apr 2026Medical Devices & Rad Health
Jiangxi Yikang Medical Instrument Group Co., Ltd.26 Mar 2026Medical Devices & Rad HealthOn file
MAXSTAR Industrial Co., Ltd.19 Mar 2026Medical Devices & Rad HealthOn file
ASEPTIKITS, LLC3 Dec 2025Medical Devices & Rad HealthOn file
Integra LifeSciences Corporation17 Sep 2025Medical Devices & Rad Health

Sites inspected

Xiamen Compower Medical Tech Co., Ltd.Xiamen, China1 insp.
Jiangxi Yikang Medical Instrument Group Co., Ltd.Nanchang, China1 insp.
MAXSTAR Industrial Co., Ltd.Gimpo, Korea (the Republic of)1 insp.
ASEPTIKITS, LLCNorth Salt Lake, United States1 insp.
Integra LifeSciences CorporationSalt Lake City, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Jessie E Morris5 shared
Rebecca L Stephany4 shared
Christina A Mayer4 shared
Janet Pulver4 shared
Brent W Higgs4 shared
Jennifer L Wolfe4 shared
Nathan R Moon3 shared
Ginger M Sykes3 shared
Katlin N Stubbs2 shared
Matthew M Vernon2 shared

Full investigator report

Get the verbatim findings behind James R Montero's 1,327 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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