Atlas

Form 483

Boiron Freres SAS Form 483, 2011-12-16

FDA issued a Form 483 to Boiron Freres SAS on 2011-12-16 with 3 public-safe observations.

483· Form 483 issued3 observations

Boiron Freres SAS · Chateauneuf-Sur-Isere, France · Issued December 16, 2011

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.

16 Dec 2011
21 CFR 120.8(b)(1)

HACCP plan - food hazards not listed

Cited by Seri L Essary

16 Dec 2011
21 CFR 120.11(b)

HACCP plan - not validated

Cited by Seri L Essary

16 Dec 2011
21 CFR 120.24(a)

Process controls - HACCP plan - 5 log reduction

Cited by Seri L Essary

Inspected site

BFBoiron Freres SASChateauneuf-Sur-Isere, France

Inspection team

SLSeri L Essary

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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