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Facility profile

Societal CDMO Gainesville, LLC

Testing & analysis · Drug product manufacturing · Gainesville, GA

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.

AnalysisLabelManufacturePack
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)

Nov 19, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

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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 history7 inspection records

FDA inspection history

7 records, Mar 2010 – Nov 2024 · 5 NAI · 2 VAI · 0 OAI

DateClassProject areaCitationsFY
Nov 19, 2024VAIDrug Quality AssuranceYes2025
Jan 24, 2018VAIDrug Quality AssuranceYes2018
Jan 31, 2017NAIDrug Quality Assurance2017
Mar 18, 2014NAIDrug Quality Assurance2014
Nov 17, 2011NAIDrug Quality Assurance2012
Dec 21, 2010NAIDrug Quality Assurance2011
Mar 24, 2010NAIDrug Quality Assurance2010

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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