Form 483

Tradewind Seafood, Inc. Form 483, 2012-08-17

FDA issued a Form 483 to Tradewind Seafood, Inc. on 2012-08-17 with 14 public-safe observations.

483· Form 483 issued14 observations

Tradewind Seafood, Inc. · Oxnard, United States · Issued August 17, 2012

Overview

  • 14 public-safe observations are available for this inspection.
  • 13 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.

17 Aug 2012
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Lilly O Barton, Kevin T Gerrity

17 Aug 2012
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Lilly O Barton, Kevin T Gerrity

17 Aug 2012
21 CFR 110.20(a)(1)

Harborage areas

Cited by Lilly O Barton, Kevin T Gerrity

17 Aug 2012
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Lilly O Barton, Kevin T Gerrity

17 Aug 2012
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Lilly O Barton, Kevin T Gerrity

Inspected site

TSTradewind Seafood, Inc.Oxnard, 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 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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