Form 483

La Hacienda Tortilleria Inc Form 483, 2011-07-26

FDA issued a Form 483 to La Hacienda Tortilleria Inc on 2011-07-26 with 2 public-safe observations.

483· Form 483 issued2 observations

La Hacienda Tortilleria Inc · Nashville, United States · Issued July 26, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

26 Jul 2011
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Thomas B Smith, Marshall H Kinsey

26 Jul 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Thomas B Smith, Marshall H Kinsey

Inspected site

LHLa Hacienda Tortilleria IncNashville, 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 110.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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