Form 483

Well Luck Co. Inc. Form 483, 2014-08-07

FDA issued a Form 483 to Well Luck Co. Inc. on 2014-08-07 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Well Luck Co. Inc. · Atlanta, United States · Issued August 7, 2014

Overview

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

Inspectional observations

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

7 Aug 2014
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Jessica Fields, Karen L Anderson, Lorenzo Jones

7 Aug 2014
21 CFR 110.20(a)(1)

Harborage areas

Cited by Jessica Fields, Karen L Anderson, Lorenzo Jones

7 Aug 2014
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Jessica Fields, Karen L Anderson, Lorenzo Jones

7 Aug 2014
21 CFR 110.20(b)(7)

Screening

Cited by Jessica Fields, Karen L Anderson, Lorenzo Jones

7 Aug 2014
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jessica Fields, Karen L Anderson, Lorenzo Jones

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 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

Every observation in full, 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