Form 483

Dallas Tortilla Inc. Form 483, 2011-01-28

FDA issued a Form 483 to Dallas Tortilla Inc. on 2011-01-28 with 13 public-safe observations.

483· Form 483 issued13 observations

Dallas Tortilla Inc. · Dallas, United States · Issued January 28, 2011

Overview

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

28 Jan 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Chad J Whitwell, Toby-Vern H Hill, Benjamin K Kingsley

28 Jan 2011
21 CFR 110.10(b)(4)

Hand jewelry - remove/cover

Cited by Chad J Whitwell, Toby-Vern H Hill, Benjamin K Kingsley

28 Jan 2011
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Chad J Whitwell, Toby-Vern H Hill, Benjamin K Kingsley

28 Jan 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Chad J Whitwell, Toby-Vern H Hill, Benjamin K Kingsley

28 Jan 2011
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Chad J Whitwell, Toby-Vern H Hill, Benjamin K Kingsley

Inspected site

DTDallas Tortilla Inc.Dallas, United States

Inspection team

BKBenjamin K Kingsley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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