Form 483

Key to the Mountain LLC Form 483, 2009-09-15

FDA issued a Form 483 to Key to the Mountain LLC on 2009-09-15 with 5 public-safe observations.

483· Form 483 issued5 observations

Key to the Mountain LLC · Saint Ignatius, United States · Issued September 15, 2009

Overview

  • 5 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.

15 Sep 2009
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Timothy D Evans

15 Sep 2009
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Timothy D Evans

15 Sep 2009
21 CFR 114.80(a)(2)

pH testing

Cited by Timothy D Evans

15 Sep 2009
21 CFR 114.100(b)

Processing and production - required information

Cited by Timothy D Evans

15 Sep 2009
21 CFR 114.100(c)

Process deviations- identification and records

Cited by Timothy D Evans

Inspected site

KTKey to the Mountain LLCSaint Ignatius, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 114.100(c)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)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