Form 483

Selecta Seafoods, Inc. Form 483, 2016-08-17

FDA issued a Form 483 to Selecta Seafoods, Inc. on 2016-08-17 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Selecta Seafoods, Inc. · Chula Vista, United States · Issued August 17, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Aug 2016
21 CFR 123.12(d)

Determination of compliance

Cited by John R Myung

17 Aug 2016
21 CFR 123.9(a)

Records - content

Cited by John R Myung

Inspected site

SSSelecta Seafoods, Inc.Chula Vista, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(d)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)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