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Facility profile

American Distilling Inc.

Drug product manufacturing · Active pharmaceutical ingredient (API) manufacturing · East Hampton, CT

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.

Active pharmaceutical ingredient (API) manufactureManufacture
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)

Apr 26, 2022 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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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 history8 inspection records

FDA inspection history

8 records, Sep 2009 – Apr 2022 · 4 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Apr 26, 2022VAIDrug Quality AssuranceYes2022
Feb 17, 2016NAIColors and Cosmetics TechnologyYes2016
Feb 17, 2016VAIDrug Quality AssuranceYes2016
Jul 26, 2013NAIFoodborne Biological Hazards2013
Jul 26, 2013NAIColors and Cosmetics Technology2013
Dec 17, 2010VAIDrug Quality Assurance2011
Dec 17, 2010VAIDrug Quality AssuranceYes2011
Sep 4, 2009NAIDrug Quality AssuranceYes2009

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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