Form 483

Extra Virgin LLC Form 483, 2020-03-05

FDA issued a Form 483 to Extra Virgin LLC on 2020-03-05 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Extra Virgin LLC · Portland, United States · Issued March 5, 2020

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

5 Mar 2020
21 CFR 123.11(c)

Sanitation Records

Cited by Jeff A Gard

5 Mar 2020
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Jeff A Gard

5 Mar 2020
21 CFR 123.6(c)(2)

Monitoring - none

Cited by Jeff A Gard

5 Mar 2020
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Jeff A Gard

5 Mar 2020
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Jeff A Gard

Inspected site

EVExtra Virgin LLCPortland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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