Atlas

Form 483

Opella Healthcare International SAS Form 483, 2013-09-19

FDA issued a Form 483 to Opella Healthcare International SAS on 2013-09-19 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Opella Healthcare International SAS · Compiegne, France · Issued September 19, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

19 Sep 2013
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Michael H Tollon, Sarah E Mcmullen

19 Sep 2013
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Michael H Tollon, Sarah E Mcmullen

19 Sep 2013
21 CFR 211.192

Written record of investigation incomplete

Cited by Michael H Tollon, Sarah E Mcmullen

Inspected site

OHOpella Healthcare International SASCompiegne, France

Inspection team

MHMichael H Tollon
SESarah E Mcmullen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)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