Form 483

Well Luck Co. Inc. Form 483, 2024-08-21

FDA issued a Form 483 to Well Luck Co. Inc. on 2024-08-21 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Well Luck Co. Inc. · Atlanta, United States · Issued August 21, 2024

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

21 Aug 2024
21 CFR 117.126(a)(1)

Food safety plan

Cited by Janet B Gray

21 Aug 2024
21 CFR 117.136(a)(2)

Customer disclosure

Cited by Janet B Gray

21 Aug 2024
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Janet B Gray

21 Aug 2024
21 CFR 117.4

Qualifications of individuals

Cited by Janet B Gray

Inspected site

WLWell Luck Co. Inc.Atlanta, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.136(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited 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