Form 483

True World Foods Columbus LLC Form 483, 2012-12-11

FDA issued a Form 483 to True World Foods Columbus LLC on 2012-12-11 with 11 public-safe observations.

483· Form 483 issued11 observations

True World Foods Columbus LLC · Columbus, United States · Issued December 11, 2012

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

11 Dec 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Darren S Morgan

11 Dec 2012
21 CFR 123.6(c)(2)

Critical control points

Cited by Darren S Morgan

11 Dec 2012
21 CFR 123.6(c)(3)

Critical limits

Cited by Darren S Morgan

11 Dec 2012
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Darren S Morgan

11 Dec 2012
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Darren S Morgan

Inspected site

TWTrue World Foods Columbus LLCColumbus, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)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 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x
21 CFR 123.9(b)(1)Cited across public-safe Form 483 observations1x
FDCA 417(d)(1)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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