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Facility profile

Professional Disposables International, Inc.

Testing & analysis · Drug product manufacturing · Orangeburg, NY

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)

Mar 31, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Jan 2022

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

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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 history14 inspection records

FDA inspection history

14 records, Oct 2008 – Mar 2026 · 4 NAI · 9 VAI · 1 OAI

DateClassProject areaCitationsFY
Mar 31, 2026VAIDrug Quality AssuranceYes2026
Sep 19, 2025NAIPostmarket Assurance: Devices2025
Sep 19, 2025NAICompliance: Devices2025
Jun 23, 2021OAIDrug Quality Assurance2021
Dec 1, 2017VAIDrug Quality AssuranceYes2018
Dec 9, 2015VAIDrug Quality AssuranceYes2016
Jun 13, 2013VAICompliance: Devices2013
Jun 13, 2013NAIPostmarket Assurance: Devices2013
Oct 18, 2011VAIDrug Quality AssuranceYes2012
Jul 5, 2011VAIDrug Quality AssuranceYes2011
Apr 20, 2011VAIDrug Quality AssuranceYes2011
Apr 20, 2011NAICompliance: DevicesYes2011
Oct 21, 2010VAIDrug Quality AssuranceYes2011
Oct 29, 2008VAIDrug Quality AssuranceYes2009

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

Matched compliance actions

Jan 7, 2022Warning 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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