Form 483

FRELLO FRESH, LLC Form 483, 2021-05-27

FDA issued a Form 483 to FRELLO FRESH, LLC on 2021-05-27 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

FRELLO FRESH, LLC · Rio Rico, United States · Issued May 27, 2021

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.

27 May 2021
21 CFR 1.505(b)

Supplier approval - document

Cited by Luis A Salinas

27 May 2021
21 CFR 1.506(e)(1)(i)(B)

Audit - food safety regulation, plan

Cited by Luis A Salinas

27 May 2021
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Luis A Salinas

Inspected site

FFFRELLO FRESH, LLCRio Rico, United States

Inspection team

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(e)(1)(i)(B)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