Atlas

Form 483

Pacific Shellfish, Inc Form 483, 2016-04-01

FDA issued a Form 483 to Pacific Shellfish, Inc on 2016-04-01 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Pacific Shellfish, Inc · San Diego, United States · Issued April 1, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

1 Apr 2016
21 CFR 123.11(b)

Sanitation monitoring

Cited by Garrad R Poole, Sara J Dent Acosta

1 Apr 2016
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Garrad R Poole, Sara J Dent Acosta

1 Apr 2016
21 CFR 123.12(a)(2)

Importer verification

Cited by Garrad R Poole, Sara J Dent Acosta

1 Apr 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Garrad R Poole, Sara J Dent Acosta

1 Apr 2016
21 CFR 123.9(a)

Records entries - timing

Cited by Garrad R Poole, Sara J Dent Acosta

Inspected site

PSPacific Shellfish, IncSan Diego, United States

Inspection team

GRGarrad R Poole
SJSara J Dent Acosta

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations2x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)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 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