Labverity
Facility profile

Isomedix Operations Inc.

Sterile processing · Chester, NY

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed9 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.

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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)

Dec 12, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

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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 history10 inspection records

FDA inspection history

10 records, Apr 2011 – Dec 2024 · 6 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 12, 2024VAIPostmarket Assurance: Devices2025
Dec 12, 2024VAICompliance: Devices2025
Jun 6, 2024NAIDrug Quality Assurance2024
Feb 16, 2023VAICompliance: DevicesYes2023
Feb 18, 2022NAICompliance: Devices2022
Nov 4, 2019VAICompliance: DevicesYes2020
Jun 2, 2015NAIHuman Cellular, Tissue, and Gene Therapies2015
Jun 2, 2015NAICompliance: Devices2015
Jan 16, 2013NAICompliance: Devices2013
Apr 11, 2011NAICompliance: Devices2011

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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