Atlas

Form 483

K & M Citrus Inc. Form 483, 2016-03-03

FDA issued a Form 483 to K & M Citrus Inc. on 2016-03-03 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

K & M Citrus Inc. · Weirsdale, United States · Issued March 3, 2016

Overview

  • 6 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 Mar 2016
21 CFR 110.35(d)(1)

Wet cleaning

Cited by Leslie A Jackanicz

3 Mar 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Leslie A Jackanicz

3 Mar 2016
21 CFR 110.35(d)(1)

Wet cleaning

Cited by Leslie A Jackanicz

3 Mar 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Leslie A Jackanicz

3 Mar 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Leslie A Jackanicz

Inspected site

K&K & M Citrus Inc.Weirsdale, United States

Inspection team

LALeslie A Jackanicz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)(1)Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 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