Atlas

Form 483

Blue Moose of Boulder, LLC Form 483, 2020-01-31

FDA issued a Form 483 to Blue Moose of Boulder, LLC on 2020-01-31 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Blue Moose of Boulder, LLC · Lafayette, United States · Issued January 31, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

31 Jan 2020
21 CFR 117.160(a)

Process Controls Validation Not Performed

Cited by Gina M Scholze

31 Jan 2020
21 CFR 117.160(a)

Process Controls Validation Not Performed

Cited by Gina M Scholze

31 Jan 2020
21 CFR 117.415(a)(2)

Supply-Chain Appropriate Verification Activities

Cited by Gina M Scholze

31 Jan 2020
21 CFR 117.415(a)(2)

Supply-Chain Appropriate Verification Activities

Cited by Gina M Scholze

Inspected site

BMBlue Moose of Boulder, LLCLafayette, United States

Inspection team

GMGina M Scholze

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.160(a)Cited across public-safe Form 483 observations2x
21 CFR 117.415(a)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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