Atlas

Form 483

Bowles Packaging Co., Inc. Form 483, 2019-11-18

FDA issued a Form 483 to Bowles Packaging Co., Inc. on 2019-11-18 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Bowles Packaging Co., Inc. · West Jordan, United States · Issued November 18, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

18 Nov 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Jennifer A Robinson

18 Nov 2019
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Jennifer A Robinson

18 Nov 2019
21 CFR 117.405(a)(1)

Supply-Chain Program Establish and Implement

Cited by Jennifer A Robinson

Inspected site

BPBowles Packaging Co., Inc.West Jordan, United States

Inspection team

JAJennifer A Robinson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.145(a)Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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