Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-14.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Aug 2025 – 14 Aug 2025 | Human Drugs | Clean | |
| 10 Feb 2025 – 14 Feb 2025 | Biologics | 483 | View 483 → |
| 24 Feb 2020 – 28 Feb 2020 | Human Drugs | Clean | |
| 10 Jul 2018 – 19 Jul 2018 | Human Drugs | Clean | |
| 15 Aug 2016 – 18 Aug 2016 | Human Drugs | 483 | View 483 → |
| 15 Sep 2014 – 18 Sep 2014 | Human Drugs | Clean | |
| 9 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | On file |
| 1 Apr 2013 – 9 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 17 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Feb 2025
21 CFR 211.130
Procedures are written, and followed
Cited by Priscilla M Pastrana, Lizaida Perez
14 Feb 2025
21 CFR 211.130(d)
Examination of packaging and labeling
Cited by Priscilla M Pastrana, Lizaida Perez
14 Feb 2025
21 CFR 211.192
No written record of investigation
Cited by Priscilla M Pastrana, Lizaida Perez
Investigators
FDA investigators tied to this site in the record.
Janet A Rajan1 insp.
Ifechimere I Okafor1 insp.
Priscilla M Pastrana1 insp.
Lizaida Perez1 insp.
Robert J Martin1 insp.
Erik W Koester1 insp.
John P Mistler1 insp.
Arie Menachem1 insp.
Mark E Parmon1 insp.
Stacey S Degarmo1 insp.
Jennifer T Szymanski1 insp.
Camerson E Moore1 insp.
Debra M Emerson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Genzyme Corporation's 3 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