Form 483

Acadian Fish Co, LLC Form 483, 2024-07-17

FDA issued a Form 483 to Acadian Fish Co, LLC on 2024-07-17 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Acadian Fish Co, LLC · Irvine, United States · Issued July 17, 2024

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.

17 Jul 2024
21 CFR 117.37

Sanitary facilities and controls

Cited by Desiree C Iya

17 Jul 2024
21 CFR 123.12(a)(2)

Importer verification

Cited by Desiree C Iya

17 Jul 2024
21 CFR 123.6(b)

HACCP plan implementation

Cited by Desiree C Iya

Inspected site

AFAcadian Fish Co, LLCIrvine, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.37Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)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