Form 483

Winchester Bay Fisheries, LLC. Form 483, 2010-09-16

FDA issued a Form 483 to Winchester Bay Fisheries, LLC. on 2010-09-16 with 6 public-safe observations.

483· Form 483 issued6 observations

Winchester Bay Fisheries, LLC. · Winchester Bay, United States · Issued September 16, 2010

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

16 Sep 2010
21 CFR 113.100(b)

Review not signed/dated

Cited by Jonathan T Little

16 Sep 2010
21 CFR 123.6(c)(2)

Critical control points

Cited by Jonathan T Little

16 Sep 2010
21 CFR 123.8(a)

Verification - reviewers qualifications

Cited by Jonathan T Little

16 Sep 2010
21 CFR 123.10

HACCP training or qualification

Cited by Jonathan T Little

16 Sep 2010
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 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.16Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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