Form 483

Martins Kitchen LLC Form 483, 2018-01-09

FDA issued a Form 483 to Martins Kitchen LLC on 2018-01-09 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Martins Kitchen LLC · Dundee, United States · Issued January 9, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

9 Jan 2018
21 CFR 110.35(b)(1)

Safe and adequate for use

Cited by Wendy M Stone

9 Jan 2018
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by Wendy M Stone

Inspected site

MKMartins Kitchen LLCDundee, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)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