Form 483

Premier Produce LLC Form 483, 2018-03-29

FDA issued a Form 483 to Premier Produce LLC on 2018-03-29 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Premier Produce LLC · Elizabethtown, United States · Issued March 29, 2018

Overview

  • 7 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.

29 Mar 2018
21 CFR 117.126(a)(2)

Food Safety Plan - Preparation

Cited by Holly J Rapier

29 Mar 2018
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Holly J Rapier

29 Mar 2018
21 CFR 117.130(a)(2)

Hazard Analysis - Written

Cited by Holly J Rapier

29 Mar 2018
21 CFR 117.145(c)(1)

Sanitation Controls - Monitoring Records

Cited by Holly J Rapier

29 Mar 2018
21 CFR 117.165(b)

Sanitation Controls Verif Procedures: Establish Implement

Cited by Holly J Rapier

Inspected site

PPPremier Produce LLCElizabethtown, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.130(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.145(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.165(b)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 7 observations

The source PDF, 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