Form 483

Great Ciao, Inc Form 483, 2022-04-15

FDA issued a Form 483 to Great Ciao, Inc on 2022-04-15 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Great Ciao, Inc · Golden Valley, United States · Issued April 15, 2022

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.

15 Apr 2022
21 CFR 123.12(a)(2)

Importer verification

Cited by Julie Woodberry, Rebecca L Keller

15 Apr 2022
21 CFR 123.6(c)(2)

Critical control points

Cited by Julie Woodberry, Rebecca L Keller

15 Apr 2022
21 CFR 123.6(c)(3)

Critical limits

Cited by Julie Woodberry, Rebecca L Keller

15 Apr 2022
21 CFR 123.8(d)

Verification - recordkeeping

Cited by Julie Woodberry, Rebecca L Keller

Inspected site

GCGreat Ciao, IncGolden Valley, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)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)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.8(d)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