Atlas

Form 483

Shawkea USA Form 483, 2026-04-20

FDA issued a Form 483 to Shawkea USA on 2026-04-20 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Shawkea USA · San Diego, United States · Issued April 20, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

20 Apr 2026
21 CFR 111.503

Written procedures - establish; returned dietary supplements

Cited by Gerard D Difiore

20 Apr 2026
21 CFR 111.553

Written procedures - establish; product complaint

Cited by Gerard D Difiore

Inspected site

SUShawkea USASan Diego, United States

Inspection team

GDGerard D Difiore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x

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