Atlas

FDA-Inspected Site

Genzyme Corporation

13 FDA inspections are on record for Genzyme Corporation in Cambridge, United States.

Clean· No action indicated

Cambridge, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2016-08-10.

At a glance

Inspections

13

Form 483s

4

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Aug 2016 – 10 Aug 2016Human DrugsClean
14 Aug 2014 – 22 Aug 2014Human DrugsClean
18 Mar 2014 – 25 Mar 2014Human DrugsClean
20 Sep 2013 – 30 Sep 2013Human Drugs483On file
5 Oct 2012Not recordedClean
28 Jun 2011Not recorded483View 483 →
2 Jun 2010Not recorded483View 483 →
9 Sep 2009Not recordedClean
20 Oct 2008Not recorded483View 483 →
17 Jan 2008Not recordedClean
19 Oct 2006Not recordedClean
13 Sep 2004Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

28 Jun 2011
21 CFR 211.165(e)

Test methods

Cited by Stacey S Degarmo, Mary-Jeanet Mcgarry

28 Jun 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Stacey S Degarmo, Mary-Jeanet Mcgarry

2 Jun 2010
21 CFR 314.80(c)

Failure by applicant to report ADE

Cited by Debra M Emerson, Stacey S Degarmo

2 Jun 2010
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Debra M Emerson, Stacey S Degarmo

2 Jun 2010
21 CFR 314.80(c)(1)(ii)

Submission of report follow-up

Cited by Debra M Emerson, Stacey S Degarmo

Investigators

FDA investigators tied to this site in the record.

Stacey S Degarmo3 insp.
Debra M Emerson2 insp.
John P Mistler1 insp.
Danielle Pearson1 insp.
Justine M Corson1 insp.
Darin S Wiegers1 insp.
Susanne M Richardson1 insp.
Mary-Jeanet Mcgarry1 insp.
John S Hartford1 insp.
Michelle M Noe1 insp.
Kent A Conforti1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Genzyme Corporation's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat