Form 483

La Hacienda Tortilleria Inc Form 483, 2009-06-25

FDA issued a Form 483 to La Hacienda Tortilleria Inc on 2009-06-25 with 8 public-safe observations.

483· Form 483 issued8 observations

La Hacienda Tortilleria Inc · Nashville, United States · Issued June 25, 2009

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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 Jun 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Cheryl G Scott

25 Jun 2009
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Cheryl G Scott

25 Jun 2009
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Cheryl G Scott

25 Jun 2009
21 CFR 110.20(b)(7)

Screening

Cited by Cheryl G Scott

25 Jun 2009
21 CFR 110.35(b)(2)

Storage requirements

Cited by Cheryl G Scott

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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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