FDA-Inspected Site

EUROSIREL S.P.A

2 FDA inspections are on record for EUROSIREL S.P.A in Cusago, Italy.

483· Form 483 issued

Cusago, Italy · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-26.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Sep 2025 – 26 Sep 2025Human Drugs483View 483 →
20 May 2024 – 24 May 2024Human DrugsWLOn file

Observations on record

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

26 Sep 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Shanna N Purdy

26 Sep 2025
21 CFR 211.166(a)

Lack of written stability program

Cited by Shanna N Purdy

26 Sep 2025
21 CFR 211.182

Written records kept in individual logs

Cited by Shanna N Purdy

26 Sep 2025
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Shanna N Purdy

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited 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 EUROSIREL S.P.A's 2 Form 483s

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