Form 483

King Produce LLC. Form 483, 2022-12-01

FDA issued a Form 483 to King Produce LLC. on 2022-12-01 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

King Produce LLC. · Pharr, United States · Issued December 1, 2022

Overview

  • 9 public-safe observations are available for this inspection.
  • 8 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.

1 Dec 2022
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Bernardino E Mendez

1 Dec 2022
21 CFR 1.505(c)(1)

Continue to import, change activities

Cited by Bernardino E Mendez

1 Dec 2022
21 CFR 1.505(c)(1)

Revaluate - new information

Cited by Bernardino E Mendez

1 Dec 2022
21 CFR 1.505(c)(2)

Reevaluate - document

Cited by Bernardino E Mendez

1 Dec 2022
21 CFR 1.506(a)(1)

Unapproved supplier procedures - importer established

Cited by Bernardino E Mendez

Inspected site

KPKing Produce LLC.Pharr, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.505(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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