Form 483

Sunshine Peanut Company Form 483, 2022-02-18

FDA issued a Form 483 to Sunshine Peanut Company on 2022-02-18 with 18 public-safe observations.

483· Form 483 issuedFoods & Cosmetics18 observations

Sunshine Peanut Company · Jacksonville, United States · Issued February 18, 2022

Overview

  • 18 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

18 Feb 2022
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Matthew B Thomaston, Melinda B Lewis

18 Feb 2022
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Matthew B Thomaston, Melinda B Lewis

18 Feb 2022
21 CFR 117.135(c)(1)

Process Controls Procedures - Adequate

Cited by Matthew B Thomaston, Melinda B Lewis

18 Feb 2022
21 CFR 117.135(c)(1)

Process Controls Procedures - Adequate

Cited by Matthew B Thomaston, Melinda B Lewis

18 Feb 2022
21 CFR 117.145(c)(1)

Sanitation Controls - Monitoring Records

Cited by Matthew B Thomaston, Melinda B Lewis

Inspected site

SPSunshine Peanut CompanyJacksonville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.145(c)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.35(a)Cited across public-safe Form 483 observations3x
21 CFR 117.37Cited across public-safe Form 483 observations3x
21 CFR 117.40Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 18 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