Form 483

Kaiser Foodline LLC Form 483, 2011-02-16

FDA issued a Form 483 to Kaiser Foodline LLC on 2011-02-16 with 9 public-safe observations.

483· Form 483 issued9 observations

Kaiser Foodline LLC · Garland, United States · Issued February 16, 2011

Overview

  • 9 public-safe observations are available for this inspection.
  • 8 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.

16 Feb 2011
21 CFR 108.25(c)(2)

Process filing

Cited by Lourdes R Genera, Seri L Essary, Coleen L Manoy

16 Feb 2011
21 CFR 108.25(e)

Recall procedures

Cited by Lourdes R Genera, Seri L Essary, Coleen L Manoy

16 Feb 2011
21 CFR 114.80(a)

Quality control procedures

Cited by Lourdes R Genera, Seri L Essary, Coleen L Manoy

16 Feb 2011
21 CFR 114.80(a)(4)

Container testing

Cited by Lourdes R Genera, Seri L Essary, Coleen L Manoy

16 Feb 2011
21 CFR 114.80(b)

Code - packing period

Cited by Lourdes R Genera, Seri L Essary, Coleen L Manoy

Inspected site

KFKaiser Foodline LLCGarland, United States

Inspection team

CLColeen L Manoy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.80(b)Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.25(e)Cited across public-safe Form 483 observations1x
21 CFR 114.100(a)Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 114.100(d)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(4)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