Atlas

Form 483

Ocean Group Inc. Form 483, 2012-05-31

FDA issued a Form 483 to Ocean Group Inc. on 2012-05-31 with 4 public-safe observations.

483· Form 483 issued4 observations

Ocean Group Inc. · Los Angeles, United States · Issued May 31, 2012

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.

31 May 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Kimberly M Lichter, Ka L Wong

31 May 2012
21 CFR 123.6(b)

No HACCP plan

Cited by Kimberly M Lichter, Ka L Wong

31 May 2012
21 CFR 123.11(b)

Sanitation monitoring

Cited by Kimberly M Lichter, Ka L Wong

31 May 2012
21 CFR 123.12(a)(2)

Importer verification

Cited by Kimberly M Lichter, Ka L Wong

Inspected site

OGOcean Group Inc.Los Angeles, United States

Inspection team

KMKimberly M Lichter
KLKa L Wong

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 123.12(a)(2)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