Form 483

Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. Form 483, 2009-09-01

FDA issued a Form 483 to Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. on 2009-09-01 with 6 public-safe observations.

483· Form 483 issued6 observations

Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. · Las Cruces, United States · Issued September 1, 2009

Overview

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

1 Sep 2009
21 CFR 108.25(c)(2)

Process filing

Cited by Carla R Hinz

1 Sep 2009
21 CFR 110.20(b)(5)

Adequate lighting

Cited by Carla R Hinz

1 Sep 2009
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Carla R Hinz

1 Sep 2009
21 CFR 110.20(b)(7)

Screening

Cited by Carla R Hinz

1 Sep 2009
21 CFR 110.37(e)(4)

Devices and fixtures

Cited by Carla R Hinz

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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