Form 483

Crown Fish Co Form 483, 2023-10-24

FDA issued a Form 483 to Crown Fish Co on 2023-10-24 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Crown Fish Co · Bronx, United States · Issued October 24, 2023

Overview

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

Inspectional observations

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

24 Oct 2023
21 CFR 123.11(b)

Sanitation monitoring

Cited by Melissa N Gregorio, Tamara M Simpson

24 Oct 2023
21 CFR 123.6(c)(3)

Critical limits

Cited by Melissa N Gregorio, Tamara M Simpson

24 Oct 2023
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Melissa N Gregorio, Tamara M Simpson

24 Oct 2023
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Melissa N Gregorio, Tamara M Simpson

Inspected site

CFCrown Fish CoBronx, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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