Atlas

Form 483

Almirall, S.A. Form 483, 2017-05-12

FDA issued a Form 483 to Almirall, S.A. on 2017-05-12 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Almirall, S.A. · Sant Feliu de Llobregat, Spain · Issued May 12, 2017

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.

12 May 2017
21 CFR 211.160(b)(2)

In-process sample representation/identification

Cited by Saied A Asbagh

12 May 2017
21 CFR 211.192

Written record of investigation incomplete

Cited by Saied A Asbagh

12 May 2017
21 CFR 211.80(b)

Handling and Storage to Prevent Contamination

Cited by Saied A Asbagh

Inspected site

ASAlmirall, S.A.Sant Feliu de Llobregat, Spain

Inspection team

SASaied A Asbagh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.80(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