Atlas

FDA-Inspected Site

Chiesi Farmaceutici S.p.A.

5 FDA inspections are on record for Chiesi Farmaceutici S.p.A. in Parma, Italy.

483· Form 483 issued

Parma, Italy · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-28.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Mar 2025 – 28 Mar 2025Human Drugs483On file
3 Apr 2023 – 11 Apr 2023Human Drugs483On file
16 May 2019 – 24 May 2019Human Drugs483View 483 →
19 Jul 2018 – 26 Jul 2018Human Drugs483On file
21 Jul 2016 – 29 Jul 2016Human Drugs483View 483 →

Observations on record

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

24 May 2019
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Saleem A Akhtar, Scott R Nichols

24 May 2019
21 CFR 211.160(b)(3)

Acceptance of drug products

Cited by Saleem A Akhtar, Scott R Nichols

24 May 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Saleem A Akhtar, Scott R Nichols

24 May 2019
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Saleem A Akhtar, Scott R Nichols

29 Jul 2016
21 CFR 211.192

No written record of investigation

Cited by Michael A Charles

Investigators

FDA investigators tied to this site in the record.

Madushini N Dharmasena1 insp.
Maria G Gutierrez-Hoffman1 insp.
Jose M Cayuela1 insp.
Thuy T Nguyen1 insp.
Jeanne M Fringer1 insp.
Saleem A Akhtar1 insp.
Scott R Nichols1 insp.
Alan P Kurtzberg1 insp.
Michael A Charles1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.56(a)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Chiesi Farmaceutici S.p.A.'s 5 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