FDA-Inspected Site

Eurofarma Laboratorios S/A

1 FDA inspection is on record for Eurofarma Laboratorios S/A in Itapevi, Brazil.

483· Form 483 issued

Itapevi, Brazil · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2022-09-20.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Sep 2022 – 20 Sep 2022Human Drugs483View 483 →

Observations on record

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

20 Sep 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sony Mathews

20 Sep 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sony Mathews

20 Sep 2022
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Sony Mathews

20 Sep 2022
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Sony Mathews

20 Sep 2022
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Sony Mathews

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 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations2x
21 CFR 211.46(b)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Eurofarma Laboratorios S/A's 1 Form 483

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