Form 483

Winchester Bay Fisheries, LLC. Form 483, 2009-08-20

FDA issued a Form 483 to Winchester Bay Fisheries, LLC. on 2009-08-20 with 2 public-safe observations.

483· Form 483 issued2 observations

Winchester Bay Fisheries, LLC. · Winchester Bay, United States · Issued August 20, 2009

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

20 Aug 2009
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Nancy E Doyle

20 Aug 2009
21 CFR 123.11(b)

Sanitation monitoring

Cited by Nancy E Doyle

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 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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