Labverity
Facility profile

GC America Inc.

Drug product manufacturing · Alsip, IL

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.

Manufacture
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)

Mar 28, 2019 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · May 2026

Within five years · review the action and follow-up.

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 history8 inspection records

FDA inspection history

8 records, Feb 2010 – Mar 2019 · 4 NAI · 2 VAI · 2 OAI

DateClassProject areaCitationsFY
Mar 28, 2019VAICompliance: DevicesYes2019
Feb 26, 2018NAIDrug Quality Assurance2018
Oct 26, 2015OAICompliance: Devices2016
Jun 6, 2014NAICompliance: Devices2014
Jun 13, 2013VAICompliance: Devices2013
Jul 13, 2012OAICompliance: Devices2012
Feb 8, 2010NAICompliance: Devices2010
Feb 8, 2010NAIPostmarket Assurance: Devices2010

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

Matched compliance actions

May 19, 2026Warning Letter · CFSAN
Nov 21, 2012Warning Letter · CDRH
Unclaimed profile

Service details not yet provided

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

Ask about services