Atlas

Form 483

Blue Ocean of Colorado, Inc. Form 483, 2017-07-03

FDA issued a Form 483 to Blue Ocean of Colorado, Inc. on 2017-07-03 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Blue Ocean of Colorado, Inc. · Denver, United States · Issued July 3, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Jul 2017
21 CFR 123.11(b)

Sanitation monitoring

Cited by Donald R Hawn, Christine L Williams

3 Jul 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Donald R Hawn, Christine L Williams

3 Jul 2017
21 CFR 123.6(b)

No HACCP plan

Cited by Donald R Hawn, Christine L Williams

3 Jul 2017
21 CFR 123.6(d)

Signed and dated

Cited by Donald R Hawn, Christine L Williams

Inspected site

BOBlue Ocean of Colorado, Inc.Denver, United States

Inspection team

DRDonald R Hawn
CLChristine L Williams

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 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)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