Form 483

Winchester Bay Fisheries, LLC. Form 483, 2012-09-21

FDA issued a Form 483 to Winchester Bay Fisheries, LLC. on 2012-09-21 with 5 public-safe observations.

483· Form 483 issued5 observations

Winchester Bay Fisheries, LLC. · Winchester Bay, United States · Issued September 21, 2012

Overview

  • 5 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.

21 Sep 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Jonathan T Little

21 Sep 2012
21 CFR 123.6(b)

No HACCP plan

Cited by Jonathan T Little

21 Sep 2012
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Jonathan T Little

21 Sep 2012
21 CFR 123.8(a)(3)(i)

Monitoring record review adequacy

Cited by Jonathan T Little

21 Sep 2012
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Jonathan T Little

Inspected site

WBWinchester Bay Fisheries, LLC.Winchester Bay, United States

Inspection team

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(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)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