Atlas

Form 483

Pacific Seafood - Portland, LLC Form 483, 2016-06-30

FDA issued a Form 483 to Pacific Seafood - Portland, LLC on 2016-06-30 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Pacific Seafood - Portland, LLC · Clackamas, United States · Issued June 30, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

30 Jun 2016
21 CFR 110.80(a)(1)

Storage

Cited by Jonathan T Little, Shannon J Hall, Philippe A Cornet

30 Jun 2016
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Jonathan T Little, Shannon J Hall, Philippe A Cornet

Inspected site

PSPacific Seafood - Portland, LLCClackamas, United States

Inspection team

JTJonathan T Little
SJShannon J Hall
PAPhilippe A Cornet

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)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