Form 483

Wheeler Seafood Inc Form 483, 2019-03-22

FDA issued a Form 483 to Wheeler Seafood Inc on 2019-03-22 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Wheeler Seafood Inc · Auburn, United States · Issued March 22, 2019

Overview

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

22 Mar 2019
21 CFR 123.12(c)

Lack of records

Cited by Lesley A Swanson, Lori J Jennings

22 Mar 2019
21 CFR 123.12(d)

Determination of compliance

Cited by Lesley A Swanson, Lori J Jennings

Inspected site

WSWheeler Seafood IncAuburn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(c)Cited across public-safe Form 483 observations1x
21 CFR 123.12(d)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