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•United States

Genzyme Corporation, Framingham, MA – FDA Inspections

Inspection records and compliance data for Genzyme Corporation in Framingham, Massachusetts. 9 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected April 09, 2026.

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Company Profile

This profile covers Genzyme Corporation based in Framingham, Massachusetts, United States.

FDA Inspection History

FDA inspections
9
OAI
1
VAI
6
NAI
1
Unclassified
1
Form 483s
1
Warning letters
1

First inspected December 5, 2008. Last inspected April 9, 2026.

Most cited issue areas

  • Biological product deviation report1 inspection
  • Contamination, chemical or physical change, deterioration1 inspection
  • Contract drug products--lack of responsibility1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
April 9, 2026Not classifiedHuman Drugs1294652
July 9, 2024OAIHuman Drugs · Drug Quality Assurance1232210
July 25, 2022VAIHuman Drugs · Drug Quality Assurance1176107
February 2, 2017NAIHuman Drugs · Drug Quality Assurance1003362
November 21, 2014VAIHuman Drugs · Drug Quality Assurance904958
September 25, 2014VAIHuman Drugs · Drug Quality Assurance897241
July 13, 2012VAIHuman Drugs · Drug Quality Assurance791919
October 22, 2010VAIHuman Drugs · Drug Quality Assurance684675
December 5, 2008VAIHuman Drugs · Drug Quality Assurance554509
FDA documents

Form 483s (4)

  • Form 483s · March 18, 2026
  • Form 483s · July 9, 2024
  • Form 483s · July 25, 2022
  • Form 483s · September 4, 2020

Warning Letters (1)

  • Warning Letters · July 9, 2024

EIRs (2)

  • EIRs · June 25, 2022
  • EIRs · September 4, 2020
Other regulators (1)
  • UK MHRA · 4 inspections · last August 14, 2017
People (4)
Ying-Xin Fan
Person
Wayne E. Seifert
Person
Sean R. Marcsisin
Person
Daniel L. Zheng
Person
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ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II
Regeneron Ireland Designated Activity Company
Wuxi Biologics Co Ltd
Daito Pharmaceutical Co., Ltd.
WuXi Biologics Ireland Limited
Abbvie Biotechnology Ltd.
Company Information

Name

Genzyme Corporation

FEI Number

1220423

Address

8, 31,45,49,51,55,68,74,76,80 New York Ave., Framingham, Massachusetts 01701, United States

Country

United States

ID: b597b205-d758-426b-bc64-09970b3a1b83

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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🇪🇺+48 532-447-507
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