Form 483

Conservas Portugal Norte, Lda. Form 483, 2019-04-11

FDA issued a Form 483 to Conservas Portugal Norte, Lda. on 2019-04-11 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Conservas Portugal Norte, Lda. · Matosinhos, Portugal · Issued April 11, 2019

Overview

  • 9 public-safe observations are available for this inspection.
  • 8 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.

11 Apr 2019
21 CFR 108.35(g)

Approved school

Cited by Thomas J Hudson

11 Apr 2019
21 CFR 113.100(a)

Process records - forms missing information

Cited by Thomas J Hudson

11 Apr 2019
21 CFR 113.100(a)(1)

Still retorts

Cited by Thomas J Hudson

11 Apr 2019
21 CFR 113.87(a)

Vent not posted

Cited by Thomas J Hudson

11 Apr 2019
21 CFR 113.87(c)

Initial temperature of container contents

Cited by Thomas J Hudson

Inspected site

CPConservas Portugal Norte, Lda.Matosinhos, Portugal

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.87(a)Cited across public-safe Form 483 observations2x
21 CFR 108.35(c)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 108.35(g)Cited across public-safe Form 483 observations1x
21 CFR 113.100(a)Cited across public-safe Form 483 observations1x
21 CFR 113.100(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 113.83Cited across public-safe Form 483 observations1x
21 CFR 113.87(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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