Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-25.
At a glance
Inspections
13
Form 483s
8
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 25 Nov 2025 | Human Drugs | Clean | |
| 24 Apr 2023 – 2 May 2023 | Human Drugs | Clean | |
| 30 Jun 2022 – 8 Jul 2022 | Human Drugs | 483 | On file |
| 10 Feb 2020 – 18 Feb 2020 | Human Drugs | 483 | On file |
| 1 May 2018 – 9 May 2018 | Human Drugs | 483 | View 483 → |
| 29 Oct 2015 – 6 Nov 2015 | Human Drugs | 483 | View 483 → |
| 4 Nov 2013 – 12 Nov 2013 | Human Drugs | 483 | View 483 → |
| 16 Nov 2012 | Not recorded | 483 | On file |
| 16 Jun 2011 | Not recorded | 483 | On file |
| 9 Dec 2009 | Not recorded | 483 | On file |
| 17 Jul 2007 | Not recorded | Clean | |
| 19 Nov 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Nov 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Edmund F Mrak, Russell J Glapion
Investigators
FDA investigators tied to this site in the record.
Laurimer Kuilan-Torres1 insp.
Adam R Cooke1 insp.
Jose E Melendez1 insp.
Richard Ledwidge1 insp.
Zhong Li1 insp.
Adetutu M Gidado1 insp.
Junho Pak1 insp.
Edmund F Mrak1 insp.
Russell J Glapion1 insp.
Erika V Butler1 insp.
Michael E Maselli1 insp.
Katherine Szestypalow1 insp.
Barbara J Breithaupt1 insp.
Cynthia Jim1 insp.
Miguel A Martinez1 insp.
Larry K Austin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Serono SA's 8 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