Atlas

FDA-Inspected Site

RIO BIOFARMA BRASIL LTDA

2 FDA inspections are on record for RIO BIOFARMA BRASIL LTDA in Hortolandia, Brazil.

483· Form 483 issued

Hortolandia, Brazil · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-05-09.

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
29 Apr 2024 – 9 May 2024Human Drugs483View 483 →
25 Jul 2022 – 2 Aug 2022Human Drugs483View 483 →

Observations on record

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

9 May 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Geoffrey K Kilili, Michele L Glendenning, Ebony D Sanon, Erin A Wall

9 May 2024
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Geoffrey K Kilili, Michele L Glendenning, Ebony D Sanon, Erin A Wall

9 May 2024
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Geoffrey K Kilili, Michele L Glendenning, Ebony D Sanon, Erin A Wall

9 May 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Geoffrey K Kilili, Michele L Glendenning, Ebony D Sanon, Erin A Wall

9 May 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Geoffrey K Kilili, Michele L Glendenning, Ebony D Sanon, Erin A Wall

Investigators

FDA investigators tied to this site in the record.

Geoffrey K Kilili1 insp.
Michele L Glendenning1 insp.
Ebony D Sanon1 insp.
Erin A Wall1 insp.
Wayne D Mcgrath1 insp.

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 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 820.75(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind RIO BIOFARMA BRASIL LTDA's 2 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