Form 483

The Culinary Factory, LLC Form 483, 2019-06-28

FDA issued a Form 483 to The Culinary Factory, LLC on 2019-06-28 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

The Culinary Factory, LLC · Lockhart, United States · Issued June 28, 2019

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

28 Jun 2019
21 CFR 108.25(c)(1)

Registration

Cited by Rene R Ramirez

28 Jun 2019
21 CFR 110.37(e)(1)

Suitable locations

Cited by Rene R Ramirez

28 Jun 2019
21 CFR 117.10

Personnel

Cited by Rene R Ramirez

28 Jun 2019
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Rene R Ramirez

28 Jun 2019
21 CFR 117.405(a)(1)

Supply-Chain Program Establish and Implement

Cited by Rene R Ramirez

Inspected site

TCThe Culinary Factory, LLCLockhart, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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