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Facility profile

WINDER LABORATORIES, LLC

Drug product manufacturing · WINDER, GA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed3 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.

Manufacture
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
Official action indicated (OAI)

Aug 5, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Jan 2026

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

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Shows

Registration status and a latest matched official 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 history9 inspection records

FDA inspection history

9 records, Feb 2009 – Aug 2025 · 3 NAI · 4 VAI · 2 OAI

DateClassProject areaCitationsFY
Aug 5, 2025OAIDrug Quality AssuranceYes2025
Feb 5, 2025NAIBioresearch Monitoring2025
Mar 13, 2020VAIDrug Quality AssuranceYes2020
Jul 18, 2018OAIDrug Quality Assurance2018
Jun 9, 2017NAIDrug Quality Assurance2017
Feb 25, 2016VAIDrug Quality Assurance2016
Feb 25, 2016VAIUnapproved and Misbranded Drugs2016
Dec 3, 2015VAIDrug Quality AssuranceYes2016
Feb 10, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Jan 9, 2026Warning Letter · CDER
Mar 26, 2019Warning 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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