Atlas

Form 483

Blue Ocean of Colorado, Inc. Form 483, 2015-11-12

FDA issued a Form 483 to Blue Ocean of Colorado, Inc. on 2015-11-12 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Blue Ocean of Colorado, Inc. · Denver, United States · Issued November 12, 2015

Overview

  • 3 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.

12 Nov 2015
21 CFR 123.6(b)

HACCP plan implementation

Cited by Brittany R Laymon

12 Nov 2015
21 CFR 123.6(b)

No HACCP plan

Cited by Brittany R Laymon

12 Nov 2015
21 CFR 123.6(d)

Signed and dated

Cited by Brittany R Laymon

Inspected site

BOBlue Ocean of Colorado, Inc.Denver, United States

Inspection team

BRBrittany R Laymon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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