Form 483

Diteba Inc Form 483, 2019-07-05

FDA issued a Form 483 to Diteba Inc on 2019-07-05 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Diteba Inc · Mississauga, Canada · Issued July 5, 2019

Overview

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

Inspectional observations

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

5 Jul 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Erik W Koester

5 Jul 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Erik W Koester

Inspected site

DIDiteba IncMississauga, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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