Atlas

FDA-Inspected Site

Lotte Biologics USA, LLC

11 FDA inspections are on record for Lotte Biologics USA, LLC in East Syracuse, United States.

Clean· No action indicated

East Syracuse, United States · Last updated July 9, 2026

Overview

  • 11 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-19.

At a glance

Inspections

11

Form 483s

5

EIRs

3

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Sep 2024 – 19 Sep 2024Human DrugsClean
28 May 2019 – 5 Jun 2019Human Drugs483On file
25 Apr 2017 – 28 Apr 2017Human Drugs483On file
5 Oct 2015 – 9 Oct 2015Human DrugsClean
23 Sep 2014 – 25 Sep 2014Human Drugs483On file
4 Feb 2013 – 7 Feb 2013Human Drugs483On file
16 Dec 2010Not recordedClean
6 Nov 2009Not recorded483On file
18 Apr 2008Not recordedClean
29 Mar 2002Not recordedClean
10 Mar 2000Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Robert C Horan3 insp.
Patricia F Hughes Troost2 insp.
Edmund F Mrak1 insp.
Christian F Gomez Lugo1 insp.
John D Mcintosh1 insp.
Tamil Arasu1 insp.
Harry J Brewer1 insp.
Michelle Y Clark Stuart1 insp.
Kathryn A Nagy1 insp.

Full site report

Get the verbatim findings behind Lotte Biologics USA, LLC's 5 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat