Form 483

Tradewind Seafood, Inc. Form 483, 2020-02-25

FDA issued a Form 483 to Tradewind Seafood, Inc. on 2020-02-25 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Tradewind Seafood, Inc. · Oxnard, United States · Issued February 25, 2020

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.

25 Feb 2020
21 CFR 123.11(b)

Sanitation monitoring

Cited by Celena Ngo

25 Feb 2020
21 CFR 123.6(c)(3)

Critical limits

Cited by Celena Ngo

25 Feb 2020
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Celena Ngo

25 Feb 2020
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Celena Ngo

25 Feb 2020
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Celena Ngo

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 observations1x
21 CFR 123.6(c)(3)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

The full inspection record, as Atlas holds it, 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