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Facility profile

ScieGen Pharmaceuticals, INC.

Testing & analysis · Drug product manufacturing · Hauppauge, NY

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

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

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Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

May 15, 2026 · FDA documented observations for voluntary correction.

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 voluntary 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 history15 inspection records

FDA inspection history

15 records, Sep 2011 – May 2026 · 7 NAI · 7 VAI · 1 OAI

DateClassProject areaCitationsFY
May 15, 2026VAIDrug Quality AssuranceYes2026
Dec 19, 2025NAIBioresearch Monitoring2026
Feb 20, 2024NAIDrug Quality Assurance2024
Apr 21, 2023OAIBioresearch Monitoring2023
Sep 2, 2022VAIDrug Quality Assurance2022
Dec 20, 2021VAIDrug Quality Assurance2022
Jun 21, 2019VAIDrug Quality AssuranceYes2019
Apr 20, 2018NAIDrug Quality Assurance2018
Mar 16, 2018NAIDrug Quality Assurance2018
Mar 14, 2018NAIBioresearch Monitoring2018
Jan 9, 2015VAIBioresearch MonitoringYes2015
Jan 9, 2015VAIDrug Quality AssuranceYes2015
Sep 18, 2013NAIDrug Quality Assurance2013
Apr 2, 2013NAIDrug Quality Assurance2013
Sep 16, 2011VAIDrug Quality Assurance2011

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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