Facility

GENZYME COPORATION

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009389940
Establishment type	Manufacture Medical Device
Location	11 Forbes Road Northborough, MA, US 01532
Registration status	Active · expires 2026
Parent company	GENZYME CORPORATION (owner-operator 9002116)
Brand names	Agalsidase beta reagent; Imiglucerase reagent; Laronidase reagent; Alglucosidase alfa reagent; Avalglucosidase alfa reagent; Olipudase alpha reagent; Anti-acid alpha-glucosidase reagent

Activity by year

Recalls (1)

Devices registered here (1)

Reagents, Specific, Analyte
Product code MVU (opens in a new tab) · Class I · Pathology · 21 CFR 864.4020

Recalls & enforcement

Class IITerminated2012-06-13
Sterility of product may be compromised due to packaging defect

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GENZYME COPORATION (FEI 3009389940) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009389940-genzyme-coporation/

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