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Facility profile

Plastikon Healthcare, LLC

Testing & analysis · Drug product manufacturing · Hayward, CA

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.

AnalysisLabelManufacturePackSterilize
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
No action indicated (NAI)

Apr 30, 2024 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Warning Letter · Apr 2022

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

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

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Method and source details
View full inspection and compliance history8 inspection records

FDA inspection history

8 records, Nov 2013 – Apr 2024 · 6 NAI · 1 VAI · 1 OAI

DateClassProject areaCitationsFY
Apr 30, 2024NAIDrug Quality Assurance2024
Jan 12, 2023VAIFoodborne Biological Hazards2023
Nov 4, 2021OAIDrug Quality AssuranceYes2022
Oct 28, 2016NAIFood Composition, Standards, Labeling and Econ2017
Oct 28, 2016NAICompliance: Devices2017
Oct 28, 2016NAIDrug Quality Assurance2017
Nov 22, 2013NAICompliance: Devices2014
Nov 22, 2013NAIPostmarket Assurance: Devices2014

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

Matched compliance actions

Apr 20, 2022Warning Letter · CDER
Unclaimed profile

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