Form 483

Pacific Seafood Washington Acquisition Co., Inc. Form 483, 2013-06-19

FDA issued a Form 483 to Pacific Seafood Washington Acquisition Co., Inc. on 2013-06-19 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Pacific Seafood Washington Acquisition Co., Inc. · Federal Way, United States · Issued June 19, 2013

Overview

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

Inspectional observations

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

19 Jun 2013
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Kimberly J Proctor Jones, Gerard P De Leon, Jeffrey N Gerdes, Katherine L Arnold

19 Jun 2013
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Kimberly J Proctor Jones, Gerard P De Leon, Jeffrey N Gerdes, Katherine L Arnold

19 Jun 2013
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Kimberly J Proctor Jones, Gerard P De Leon, Jeffrey N Gerdes, Katherine L Arnold

19 Jun 2013
21 CFR 123.8(b)

Verification - corrective action

Cited by Kimberly J Proctor Jones, Gerard P De Leon, Jeffrey N Gerdes, Katherine L Arnold

19 Jun 2013
21 CFR 123.11(b)

Sanitation monitoring

Cited by Kimberly J Proctor Jones, Gerard P De Leon, Jeffrey N Gerdes, Katherine L Arnold

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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