Atlas

Form 483

Aziende Chimiche Riunite Angelini Francesco S.p.A. Form 483, 2012-01-26

FDA issued a Form 483 to Aziende Chimiche Riunite Angelini Francesco S.p.A. on 2012-01-26 with 6 public-safe observations.

483· Form 483 issued6 observations

Aziende Chimiche Riunite Angelini Francesco S.p.A. · Casella, Italy · Issued January 26, 2012

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

26 Jan 2012
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Donna L Besone

26 Jan 2012
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Donna L Besone

26 Jan 2012
21 CFR 820.40(a)

Document locations, Dissemination, etc.

Cited by Donna L Besone

26 Jan 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Donna L Besone

26 Jan 2012
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Donna L Besone

Inspected site

ACAziende Chimiche Riunite Angelini Francesco S.p.A.Casella, Italy

Inspection team

DLDonna L Besone

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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