Form 483

Sabatino North America, LLC Form 483, 2018-03-26

FDA issued a Form 483 to Sabatino North America, LLC on 2018-03-26 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Sabatino North America, LLC · West Haven, United States · Issued March 26, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

26 Mar 2018
21 CFR 113.100(b)

Review not timely

Cited by Mikayla K Deardorff, Eduardo L Rodriguez

Inspected site

SNSabatino North America, LLCWest Haven, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

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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