Form 483

Air Culinaire Form 483, 2011-01-20

FDA issued a Form 483 to Air Culinaire on 2011-01-20 with 4 public-safe observations.

483· Form 483 issued4 observations

Air Culinaire · Dallas, United States · Issued January 20, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

20 Jan 2011
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Martha S Baldwin

20 Jan 2011
21 CFR 110.40(a)

Installation and maintenance of equipment (S)

Cited by Martha S Baldwin

20 Jan 2011
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Martha S Baldwin

20 Jan 2011
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Martha S Baldwin

Inspected site

ACAir CulinaireDallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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