Atlas

Form 483

Patagonia Processing USA, Inc. Form 483, 2020-03-10

FDA issued a Form 483 to Patagonia Processing USA, Inc. on 2020-03-10 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Patagonia Processing USA, Inc. · Doral, United States · Issued March 10, 2020

Overview

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

Inspectional observations

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

10 Mar 2020
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Lissette Paiz, Megan K Otero, Stacey L Witherwax

10 Mar 2020
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Lissette Paiz, Megan K Otero, Stacey L Witherwax

Inspected site

PPPatagonia Processing USA, Inc.Doral, United States

Inspection team

LPLissette Paiz
MKMegan K Otero
SLStacey L Witherwax

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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