Form 483

Dallas Tortilla Inc. Form 483, 2009-12-31

FDA issued a Form 483 to Dallas Tortilla Inc. on 2009-12-31 with 7 public-safe observations.

483· Form 483 issued7 observations

Dallas Tortilla Inc. · Dallas, United States · Issued December 31, 2009

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 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.

31 Dec 2009
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Roy Baby

31 Dec 2009
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Roy Baby

31 Dec 2009
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Roy Baby

31 Dec 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Roy Baby

31 Dec 2009
21 CFR 110.80(a)(7)

Receipt/storage - liquid and dry raw materials

Cited by Roy Baby

Inspected site

DTDallas Tortilla Inc.Dallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(7)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)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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