Atlas

Form 483

Sialco S.A. Form 483, 2018-05-21

FDA issued a Form 483 to Sialco S.A. on 2018-05-21 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Sialco S.A. · Agadir, Morocco · Issued May 21, 2018

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.

21 May 2018
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Tara M Aikens, Tara M Mussatto

21 May 2018
21 CFR 123.6(c)(2)

Critical control points

Cited by Tara M Aikens, Tara M Mussatto

Inspected site

SSSialco S.A.Agadir, Morocco

Inspection team

TMTara M Aikens
TMTara M Mussatto

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)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