Form 483

HC Produce LLC Form 483, 2020-03-18

FDA issued a Form 483 to HC Produce LLC on 2020-03-18 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

HC Produce LLC · San Diego, United States · Issued March 18, 2020

Overview

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

Inspectional observations

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

18 Mar 2020
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Ana M Pietsch, Relina D Balingit-Ordillas, Iris C Tan

18 Mar 2020
21 CFR 1.504(c)(2)

Evaluation ready-to-eat food

Cited by Ana M Pietsch, Relina D Balingit-Ordillas, Iris C Tan

18 Mar 2020
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Ana M Pietsch, Relina D Balingit-Ordillas, Iris C Tan

Inspected site

HPHC Produce LLCSan Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.504(c)(2)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