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Facility profile

GADAL Laboratories, Inc

Drug product manufacturing · Miami, FL

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.

Manufacture
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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)

Feb 17, 2023 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Aug 2023

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

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Method and source details
View full inspection and compliance history6 inspection records

FDA inspection history

6 records, Jan 2013 – Feb 2023 · 1 NAI · 4 VAI · 1 OAI

DateClassProject areaCitationsFY
Feb 17, 2023OAIDrug Quality Assurance2023
Aug 9, 2019VAIFood Composition, Standards, Labeling and EconYes2019
Apr 28, 2016VAIDrug Quality AssuranceYes2016
Apr 28, 2016NAIFood Composition, Standards, Labeling and EconYes2016
Jan 23, 2013VAIFood Composition, Standards, Labeling and EconYes2013
Jan 23, 2013VAIDrug Quality AssuranceYes2013

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

Matched compliance actions

Aug 15, 2023Warning Letter · CDER
Unclaimed profile

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