Atlas

Form 483

Vifor Pharma Ltd Form 483, 2019-03-29

FDA issued a Form 483 to Vifor Pharma Ltd on 2019-03-29 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Vifor Pharma Ltd · Glattbrugg, Switzerland · Issued March 29, 2019

Overview

  • 1 public-safe observation is 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.

29 Mar 2019
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Lequita M Mayhew

Inspected site

VPVifor Pharma LtdGlattbrugg, Switzerland

Inspection team

LMLequita M Mayhew

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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