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Facility profile

KVK-TECH, INC.

Testing & analysis · Drug product manufacturing · NEWTOWN, PA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 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.

AnalysisLabelManufacturePack
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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)

Mar 14, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2020

More than five years old · review later records.

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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 history13 inspection records

FDA inspection history

13 records, Aug 2009 – Mar 2025 · 3 NAI · 7 VAI · 3 OAI

DateClassProject areaCitationsFY
Mar 14, 2025OAIDrug Quality AssuranceYes2025
Oct 21, 2024NAIBioresearch Monitoring2025
Jul 8, 2022OAIDrug Quality AssuranceYes2022
Apr 16, 2019OAIDrug Quality Assurance2019
Sep 21, 2018NAIBioresearch Monitoring2018
Jun 27, 2017VAIDrug Quality Assurance2017
Dec 11, 2014NAIBioresearch Monitoring2015
Dec 11, 2014VAIDrug Quality Assurance2015
Dec 9, 2013VAIDrug Quality Assurance2014
Sep 17, 2012VAIBioresearch Monitoring2012
Aug 1, 2011VAIDrug Quality Assurance2011
Dec 16, 2009VAIDrug Quality Assurance2010
Aug 31, 2009VAIDrug Quality Assurance2009

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

Matched compliance actions

Feb 11, 2020Warning Letter · CDER
Unclaimed profile

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Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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