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Form 483

RIO BIOFARMA BRASIL LTDA Form 483, 2022-08-02

FDA issued a Form 483 to RIO BIOFARMA BRASIL LTDA on 2022-08-02 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

RIO BIOFARMA BRASIL LTDA · Hortolandia, Brazil · Issued August 2, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

2 Aug 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Wayne D Mcgrath

2 Aug 2022
21 CFR 211.194(a)(6)

Comparison of Test Results to Specifications

Cited by Wayne D Mcgrath

2 Aug 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Wayne D Mcgrath

Inspected site

RBRIO BIOFARMA BRASIL LTDAHortolandia, Brazil

Inspection team

WDWayne D Mcgrath

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere