Atlas

FDA-Inspected Site

MERCK SERONO SPA

11 FDA inspections are on record for MERCK SERONO SPA in Modugno, Italy.

483· Form 483 issued

Modugno, Italy · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-05-10.

At a glance

Inspections

11

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 May 2023 – 10 May 2023Human Drugs483On file
13 Mar 2023 – 17 Mar 2023Human DrugsClean
23 May 2019 – 31 May 2019Human Drugs483View 483 →
14 May 2018 – 25 May 2018Human Drugs483View 483 →
2 May 2016 – 10 May 2016Human Drugs483View 483 →
23 Jun 2014 – 1 Jul 2014Human Drugs483View 483 →
25 Sep 2012Not recorded483View 483 →
16 Jul 2010Not recorded483On file
8 Jul 2008Not recordedClean
7 Apr 2005Not recordedClean
21 Jul 2003Not recordedClean

Observations on record

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

31 May 2019
21 CFR 211.22(c)

Approve or reject procedures or specs

Cited by Cheryl A Clausen

31 May 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cheryl A Clausen

25 May 2018
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Helen B Ricalde

25 May 2018
21 CFR 211.84(b)

Representative Samples Criteria

Cited by Helen B Ricalde

10 May 2016
21 CFR 211.160(b)(3)

Acceptance of drug products

Cited by Steven P Donald, Ivis L Negron Torres

Investigators

FDA investigators tied to this site in the record.

Richard Ledwidge1 insp.
MRA McCulloughJ1 insp.
Cheryl A Clausen1 insp.
Helen B Ricalde1 insp.
Steven P Donald1 insp.
Ivis L Negron Torres1 insp.
Marvin D Jones1 insp.
Patricia D Stahnke1 insp.
Rebecca E Dombrowski1 insp.
Susan M Jackson1 insp.
Gwyn G Dickinson1 insp.
David M Beltran1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.103Cited across public-safe Form 483 observations2x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind MERCK SERONO SPA's 7 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