Form 483

Kalahari Inc. Form 483, 2017-09-20

FDA issued a Form 483 to Kalahari Inc. on 2017-09-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Kalahari Inc. · Garland, United States · Issued September 20, 2017

Overview

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

Inspectional observations

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

20 Sep 2017
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Christopher Jacobs, Phillip J Sample

20 Sep 2017
21 CFR 110.20(b)(1)

Sufficient space

Cited by Christopher Jacobs, Phillip J Sample

20 Sep 2017
21 CFR 110.35(b)(2)

Storage requirements

Cited by Christopher Jacobs, Phillip J Sample

Inspected site

KIKalahari Inc.Garland, 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(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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