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Facility profile

TUBILUX PHARMA SPA

Testing & analysis · Drug product manufacturing · POMEZIA · Italy

FDA recordFDA directory updated Jul 21, 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.

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Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Jun 14, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2017

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

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Method and source details
View full inspection and compliance history4 inspection records

FDA inspection history

4 records, Dec 2016 – Jun 2024 · 0 NAI · 2 VAI · 2 OAI

DateClassProject areaCitationsFY
Jun 14, 2024VAIDrug Quality Assurance2024
Dec 10, 2019VAIDrug Quality Assurance2020
Apr 6, 2018OAIDrug Quality AssuranceYes2018
Dec 9, 2016OAIDrug Quality AssuranceYes2017

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

Matched compliance actions

Jul 6, 2017Warning Letter · CDER
Unclaimed profile

Service details not yet provided

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

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