Atlas

FDA-Inspected Site

ROVI Pharma Industrial Services S.A.

6 FDA inspections are on record for ROVI Pharma Industrial Services S.A. in Madrid, Spain.

Clean· No action indicated

Madrid, Spain · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-10.

At a glance

Inspections

6

Form 483s

2

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Jun 2025 – 10 Jun 2025BiologicsClean
24 Mar 2021 – 5 Apr 2021Human DrugsClean
17 Sep 2018 – 25 Sep 2018Human DrugsClean
14 Apr 2016 – 22 Apr 2016Human Drugs483View 483 →
20 Mar 2014 – 27 Mar 2014Human Drugs483View 483 →
3 Jul 2012Not recordedClean

Observations on record

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

22 Apr 2016
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Ademola O Daramola, Xiomara Copeland

22 Apr 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Ademola O Daramola, Xiomara Copeland

22 Apr 2016
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Ademola O Daramola, Xiomara Copeland

27 Mar 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

27 Mar 2014
21 CFR 211.56(b)

Written sanitation procedures lacking

Cited by Noreen Muniz

Investigators

FDA investigators tied to this site in the record.

Alan L Truong1 insp.
Brentley S Pittman1 insp.
MRA DavisM1 insp.
Linda Thai1 insp.
Ademola O Daramola1 insp.
Xiomara Copeland1 insp.
Noreen Muniz1 insp.
Christopher D Leach1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ROVI Pharma Industrial Services S.A.'s 2 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