Form 483

Maris Food GmbH Form 483, 2017-02-08

FDA issued a Form 483 to Maris Food GmbH on 2017-02-08 with 21 public-safe observations.

483· Form 483 issuedFoods & Cosmetics21 observations

Maris Food GmbH · Cuxhaven, Germany · Issued February 8, 2017

Overview

  • 21 public-safe observations are available for this inspection.
  • 7 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.

8 Feb 2017
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Thomas J Hudson

8 Feb 2017
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Thomas J Hudson

8 Feb 2017
21 CFR 108.35(g)

Approved school

Cited by Thomas J Hudson

8 Feb 2017
21 CFR 113.100(a)

Process records - forms missing information

Cited by Thomas J Hudson

8 Feb 2017
21 CFR 113.100(a)

Process records - forms missing information

Cited by Thomas J Hudson

Inspected site

MFMaris Food GmbHCuxhaven, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations3x
21 CFR 108.35(g)Cited across public-safe Form 483 observations3x
21 CFR 113.100(a)Cited across public-safe Form 483 observations3x
21 CFR 113.60(b)Cited across public-safe Form 483 observations3x
21 CFR 113.83Cited across public-safe Form 483 observations3x
21 CFR 113.87(c)Cited across public-safe Form 483 observations3x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 21 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