Form 483

Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. Form 483, 2010-08-25

FDA issued a Form 483 to Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. on 2010-08-25 with 4 public-safe observations.

483· Form 483 issued4 observations

Andele's Tortilleria de Mesilla LLC dba Ol' Gringo Chile Co. · Las Cruces, United States · Issued August 25, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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 Aug 2010
21 CFR 108.25(c)(2)

Process filing

Cited by Isabel Y Espinosa

25 Aug 2010
21 CFR 110.20(b)(7)

Screening

Cited by Isabel Y Espinosa

25 Aug 2010
21 CFR 110.37(e)(4)

Devices and fixtures

Cited by Isabel Y Espinosa

25 Aug 2010
21 CFR 114.80(a)(1)

Scheduled process

Cited by Isabel Y Espinosa

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 114.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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