Form 483

Pacific Rim Seafood, Inc. Form 483, 2014-03-11

FDA issued a Form 483 to Pacific Rim Seafood, Inc. on 2014-03-11 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Pacific Rim Seafood, Inc. · Fort Bragg, United States · Issued March 11, 2014

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

11 Mar 2014
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Nympha V Florendo, Steven M Galvez

11 Mar 2014
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Nympha V Florendo, Steven M Galvez

11 Mar 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Nympha V Florendo, Steven M Galvez

11 Mar 2014
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Nympha V Florendo, Steven M Galvez

11 Mar 2014
21 CFR 123.6(d)

Signed and dated

Cited by Nympha V Florendo, Steven M Galvez

Inspected site

PRPacific Rim Seafood, Inc.Fort Bragg, 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)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)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 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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