Form 483

La Diana Tortilla and Bakery Factory, LLC Form 483, 2013-10-25

FDA issued a Form 483 to La Diana Tortilla and Bakery Factory, LLC on 2013-10-25 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

La Diana Tortilla and Bakery Factory, LLC · North Salt Lake, United States · Issued October 25, 2013

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

25 Oct 2013
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by William A Lanier

25 Oct 2013
21 CFR 110.10(b)(6)

Failure to wear

Cited by William A Lanier

25 Oct 2013
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by William A Lanier

25 Oct 2013
21 CFR 110.20(a)(1)

Harborage areas

Cited by William A Lanier

25 Oct 2013
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by William A Lanier

Inspected site

LDLa Diana Tortilla and Bakery Factory, LLCNorth Salt Lake, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)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 10 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