Form 483

Ocean Beauty Seafoods, LLC Form 483, 2013-02-26

FDA issued a Form 483 to Ocean Beauty Seafoods, LLC on 2013-02-26 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Ocean Beauty Seafoods, LLC · Monroe, United States · Issued February 26, 2013

Overview

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

Inspectional observations

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

26 Feb 2013
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Jeffrey N Gerdes, Abby M Miller, Katherine L Arnold

26 Feb 2013
21 CFR 123.6(c)(2)

Critical control points

Cited by Jeffrey N Gerdes, Abby M Miller, Katherine L Arnold

26 Feb 2013
21 CFR 123.11(b)

Sanitation monitoring

Cited by Jeffrey N Gerdes, Abby M Miller, Katherine L Arnold

Inspected site

OBOcean Beauty Seafoods, LLCMonroe, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)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