FDA Investigator

Preston M Lee

Latest inspection on record: New York, United States, April 2026 · records back to 2018

Medical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

Overview

  • 64 inspections across 62 sites are on record.
  • 150 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-04-09.

At a glance

Inspections

64

Sites

62

Observations

150

Career since

Oct 2018

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
AUDICUS9 Apr 2026Medical Devices & Rad Health
Creodent Prosthetics Ltd.14 Jan 2026Medical Devices & Rad Health
Thoracent, LLC11 Dec 2025Medical Devices & Rad HealthOn file
Tools For Surgery, LLC6 Nov 2025Medical Devices & Rad HealthOn file
Kaneka Medical America LLC28 Aug 2025Medical Devices & Rad Health

Sites inspected

AUDICUSNew York, United States1 insp.
Creodent Prosthetics Ltd.New York, United States1 insp.
Thoracent, LLCHuntington, United States1 insp.
Tools For Surgery, LLCStony Brook, United States1 insp.
Kaneka Medical America LLCNew York, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Kwong P Lee5 shared
Colin E Tack4 shared
Emir Galevi1 shared
Stephen C Smith1 shared
Maura Rooney1 shared
Jeffrey J Thibodeau1 shared

Full investigator report

Get the verbatim findings behind Preston M Lee's 150 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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