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Facility profile

Lotte Biologics USA, LLC

Testing & analysis · Active pharmaceutical ingredient (API) manufacturing · East Syracuse, NY

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed
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Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisActive pharmaceutical ingredient (API) manufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
No action indicated (NAI)

Sep 19, 2024 · No conditions warranted FDA action in this inspection.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history7 inspection records

FDA inspection history

7 records, Apr 2009 – Sep 2024 · 3 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Sep 19, 2024NAIDrug Quality Assurance2024
Jun 5, 2019VAIDrug Quality Assurance2019
Apr 28, 2017VAIDrug Quality Assurance2017
Sep 25, 2014VAIDrug Quality Assurance2014
Jul 20, 2012VAIDrug Quality AssuranceYes2012
Aug 20, 2010NAIDrug Quality Assurance2010
Apr 16, 2009NAIDrug Quality Assurance2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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