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Form 483

Big Splash Seafoods Co Form 483, 2020-01-10

FDA issued a Form 483 to Big Splash Seafoods Co on 2020-01-10 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Big Splash Seafoods Co · Blaine, United States · Issued January 10, 2020

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Jan 2020
21 CFR 123.12(a)(2)

Importer verification

Cited by Joseph M Hudak, Kevin T Schonborn

Inspected site

BSBig Splash Seafoods CoBlaine, United States

Inspection team

JMJoseph M Hudak
KTKevin T Schonborn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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