Atlas

Form 483

Redox Srl Form 483, 2015-02-20

FDA issued a Form 483 to Redox Srl on 2015-02-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Redox Srl · Monza, Italy · Issued February 20, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

20 Feb 2015
21 CFR 211.192

No written record of investigation

Cited by Gayle S Lawson, David J Eide

20 Feb 2015
21 CFR 211.194(a)(6)

Test results, comparison with standards not included

Cited by Gayle S Lawson, David J Eide

Inspected site

RSRedox SrlMonza, Italy

Inspection team

GSGayle S Lawson
DJDavid J Eide

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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