Form 483

La Hacienda Tortilleria Inc Form 483, 2010-02-11

FDA issued a Form 483 to La Hacienda Tortilleria Inc on 2010-02-11 with 5 public-safe observations.

483· Form 483 issued5 observations

La Hacienda Tortilleria Inc · Nashville, United States · Issued February 11, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

11 Feb 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Thomas B Smith, Cheryl G Scott, Matthew G Ellison

11 Feb 2010
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Thomas B Smith, Cheryl G Scott, Matthew G Ellison

11 Feb 2010
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Thomas B Smith, Cheryl G Scott, Matthew G Ellison

11 Feb 2010
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Thomas B Smith, Cheryl G Scott, Matthew G Ellison

11 Feb 2010
21 CFR 110.35(d)

Failure to clean - general

Cited by Thomas B Smith, Cheryl G Scott, Matthew G Ellison

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)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)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)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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