Atlas

Form 483

Sea One Enterprises, Inc. Form 483, 2012-07-03

FDA issued a Form 483 to Sea One Enterprises, Inc. on 2012-07-03 with 5 public-safe observations.

483· Form 483 issued5 observations

Sea One Enterprises, Inc. · Oakwood Village, United States · Issued July 3, 2012

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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 2012
21 CFR 123.6(a)

Hazard analysis

Cited by Diane M Fresch, Annemarie H Cochran

3 Jul 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Diane M Fresch, Annemarie H Cochran

3 Jul 2012
21 CFR 123.6(b)

No HACCP plan

Cited by Diane M Fresch, Annemarie H Cochran

3 Jul 2012
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Diane M Fresch, Annemarie H Cochran

3 Jul 2012
21 CFR 123.11(b)

Sanitation monitoring

Cited by Diane M Fresch, Annemarie H Cochran

Inspected site

SOSea One Enterprises, Inc.Oakwood Village, United States

Inspection team

DMDiane M Fresch
AHAnnemarie H Cochran

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(a)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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