Atlas

FDA-Inspected Site

ROVI Pharma Industrial Services S.A.

5 FDA inspections are on record for ROVI Pharma Industrial Services S.A. in San Sebastian De Los Reyes, Spain.

483· Form 483 issued

San Sebastian De Los Reyes, Spain · Last updated July 11, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-31.

At a glance

Inspections

5

Form 483s

3

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Jan 2025 – 31 Jan 2025Biologics483View 483 →
3 Jul 2024 – 9 Jul 2024BiologicsClean
18 Sep 2023 – 22 Sep 2023Human Drugs483View 483 →
12 Sep 2023 – 18 Sep 2023BiologicsClean
6 Jun 2022 – 20 Jun 2022Human Drugs483View 483 →

Observations on record

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

31 Jan 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Unnee Ranjan, Burnell M Henry

31 Jan 2025
21 CFR 211.188(b)(2)

Identification of Equipment and Lines

Cited by Unnee Ranjan, Burnell M Henry

31 Jan 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Unnee Ranjan, Burnell M Henry

31 Jan 2025
21 CFR 211.68(b)

input/output verification

Cited by Unnee Ranjan, Burnell M Henry

22 Sep 2023
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jennifer Lalama, Dorothy P Kramer

Investigators

FDA investigators tied to this site in the record.

Unnee Ranjan1 insp.
Burnell M Henry1 insp.
Erin C Hill1 insp.
Lisa T Pham1 insp.
Jennifer Lalama1 insp.
Dorothy P Kramer1 insp.
Viviana R Ramirez1 insp.
Arsen Karapetyan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ROVI Pharma Industrial Services S.A.'s 3 Form 483s

Source PDFs 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