Atlas

Form 483

Ponce Produce, Inc. Form 483, 2024-03-14

FDA issued a Form 483 to Ponce Produce, Inc. on 2024-03-14 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Ponce Produce, Inc. · Los Angeles, United States · Issued March 14, 2024

Overview

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

14 Mar 2024
21 CFR 1.505(b)

Supplier approval - document

Cited by Jeannie Pradyanata, Arnold C Shih

14 Mar 2024
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Jeannie Pradyanata, Arnold C Shih

14 Mar 2024
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Jeannie Pradyanata, Arnold C Shih

Inspected site

PPPonce Produce, Inc.Los Angeles, United States

Inspection team

JPJeannie Pradyanata
ACArnold C Shih

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(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