Form 483

Creation Gardens, Inc Form 483, 2014-12-05

FDA issued a Form 483 to Creation Gardens, Inc on 2014-12-05 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Creation Gardens, Inc · Louisville, United States · Issued December 5, 2014

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

5 Dec 2014
21 CFR 110.35(a)

Buildings/good repair

Cited by Luckner Jean-Marie, Holly J Rapier, Krista T Ferry

5 Dec 2014
21 CFR 110.37(b)(3)

As source of contamination

Cited by Luckner Jean-Marie, Holly J Rapier, Krista T Ferry

5 Dec 2014
21 CFR 110.40(a)

Food-contact - unlawful indirect additives

Cited by Luckner Jean-Marie, Holly J Rapier, Krista T Ferry

5 Dec 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Luckner Jean-Marie, Holly J Rapier, Krista T Ferry

5 Dec 2014
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Luckner Jean-Marie, Holly J Rapier, Krista T Ferry

Inspected site

CGCreation Gardens, IncLouisville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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