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Facility profile

Genzyme Corporation

Testing-focused facility · Framingham, MA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed12 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.

Analysis
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 9, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Jan 2025

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

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 history9 inspection records

FDA inspection history

9 records, Dec 2008 – Apr 2026 · 1 NAI · 7 VAI · 1 OAI

DateClassProject areaCitationsFY
Apr 9, 2026VAIDrug Quality Assurance2026
Jul 9, 2024OAIDrug Quality Assurance2024
Jul 25, 2022VAIDrug Quality Assurance2022
Feb 2, 2017NAIDrug Quality Assurance2017
Nov 21, 2014VAIDrug Quality AssuranceYes2015
Sep 25, 2014VAIDrug Quality Assurance2014
Jul 13, 2012VAIDrug Quality Assurance2012
Oct 22, 2010VAIDrug Quality Assurance2011
Dec 5, 2008VAIDrug Quality Assurance2009

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

Matched compliance actions

Jan 15, 2025Warning 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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