Overview
- 16 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
16
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2026 – 9 Apr 2026 | Human Drugs | 483 | On file |
| 12 Jun 2024 – 9 Jul 2024 | Human Drugs | WL | On file |
| 18 Jul 2022 – 25 Jul 2022 | Human Drugs | 483 | On file |
| 26 Aug 2020 – 4 Sep 2020 | Human Drugs | 483 | On file |
| 23 Jan 2017 – 2 Feb 2017 | Human Drugs | WL | |
| 3 Nov 2014 – 21 Nov 2014 | Human Drugs | 483 | View 483 → |
| 8 Sep 2014 – 25 Sep 2014 | Human Drugs | 483 | On file |
| 13 Jul 2012 | Not recorded | 483 | On file |
| 7 Nov 2011 | Not recorded | 483 | On file |
| 22 Oct 2010 | Not recorded | 483 | On file |
| 5 Dec 2008 | Not recorded | 483 | On file |
| 14 Feb 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2014
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by John P Mistler, Mary-Jeanet Mcgarry
21 Nov 2014
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by John P Mistler, Mary-Jeanet Mcgarry
21 Nov 2014
21 CFR 600.14(a)(1)
Who must report - manufacturer
Cited by John P Mistler, Mary-Jeanet Mcgarry
21 Nov 2014
21 CFR 606.171
Biological product deviation report
Cited by John P Mistler, Mary-Jeanet Mcgarry
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin3 insp.
Ramon E Martinez3 insp.
Rory Geyer2 insp.
Paige R Mccoy1 insp.
Daniel L Zheng1 insp.
Wayne E Seifert1 insp.
Edmund F Mrak1 insp.
Jonathan G Matrisciano1 insp.
John P Mistler1 insp.
Mary-Jeanet Mcgarry1 insp.
Kalavati C Suvarna1 insp.
Stacey S Degarmo1 insp.
Megan A Haggerty1 insp.
Thomas J Arista1 insp.
Richard H Penta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Genzyme Corporation's 10 Form 483s
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