Form 483

Tradewind Seafood, Inc. Form 483, 2010-02-17

FDA issued a Form 483 to Tradewind Seafood, Inc. on 2010-02-17 with 5 public-safe observations.

483· Form 483 issued5 observations

Tradewind Seafood, Inc. · Oxnard, United States · Issued February 17, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

17 Feb 2010
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Sarah A Hassas

17 Feb 2010
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Sarah A Hassas

17 Feb 2010
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Sarah A Hassas

17 Feb 2010
21 CFR 110.37(b)(3)

As source of contamination

Cited by Sarah A Hassas

17 Feb 2010
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Sarah A Hassas

Inspected site

TSTradewind Seafood, Inc.Oxnard, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)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