Labverity
Facility profile

Janssen-Cilag Manufacturing, LLC

Testing & analysis · Drug product manufacturing · Gurabo, PR

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed21 registered company locations
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.

AnalysisManufacturePack
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)

Feb 11, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

Use the evidence, then ask for fit.

Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

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

Ask next

Ask what was corrected and review any later inspection or follow-up record.

Method and source details
View full inspection and compliance history10 inspection records

FDA inspection history

10 records, Dec 2009 – Feb 2026 · 6 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Feb 11, 2026VAIDrug Quality AssuranceYes2026
Nov 23, 2021VAIDrug Quality Assurance2022
Aug 7, 2017VAIDrug Quality Assurance2017
Jan 13, 2017NAICompliance: Devices2017
Feb 24, 2014NAICompliance: Devices2014
Oct 23, 2013NAIDrug Quality Assurance2014
Nov 22, 2011NAICompliance: Devices2012
Feb 18, 2011NAIDrug Quality Assurance2011
Dec 16, 2009VAIDrug Quality Assurance2010
Dec 3, 2009NAIPostmarket Assurance: Devices2010

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.

Ask about services