Atlas

Form 483

UCB Farchim S.A. Form 483, 2011-09-02

FDA issued a Form 483 to UCB Farchim S.A. on 2011-09-02 with 2 public-safe observations.

483· Form 483 issued2 observations

UCB Farchim S.A. · Bulle, Switzerland · Issued September 2, 2011

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.

2 Sep 2011
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Joanne E King, Luis M Burgos Medero

2 Sep 2011
21 CFR 211.101(d)

Component addition checked by 2nd person

Cited by Joanne E King, Luis M Burgos Medero

Inspected site

UFUCB Farchim S.A.Bulle, Switzerland

Inspection team

JEJoanne E King
LMLuis M Burgos Medero

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.101(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)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