Form 483

Ocracoke Seafood Co. Inc. Form 483, 2014-09-10

FDA issued a Form 483 to Ocracoke Seafood Co. Inc. on 2014-09-10 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ocracoke Seafood Co. Inc. · Ocracoke, United States · Issued September 10, 2014

Overview

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

10 Sep 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by James P Lewis

10 Sep 2014
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by James P Lewis

10 Sep 2014
21 CFR 123.9(a)

Records - content

Cited by James P Lewis

10 Sep 2014
21 CFR 123.11(b)

Sanitation monitoring

Cited by James P Lewis

Inspected site

OSOcracoke Seafood Co. Inc.Ocracoke, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)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