Form 483

Citrus Systems Inc Form 483, 2018-12-03

FDA issued a Form 483 to Citrus Systems Inc on 2018-12-03 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Citrus Systems Inc · Hopkins, United States · Issued December 3, 2018

Overview

  • 3 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.

3 Dec 2018
21 CFR 120.7(c)

All hazards not considered

Cited by Karen M Labounty

3 Dec 2018
21 CFR 120.8(a)

HACCP plan - location and type of juice

Cited by Karen M Labounty

3 Dec 2018
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Karen M Labounty

Inspected site

CSCitrus Systems IncHopkins, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.8(a)Cited across public-safe Form 483 observations2x
21 CFR 120.7(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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