Atlas

Form 483

Pacific Shellfish, Inc Form 483, 2014-10-10

FDA issued a Form 483 to Pacific Shellfish, Inc on 2014-10-10 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Pacific Shellfish, Inc · San Diego, United States · Issued October 10, 2014

Overview

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

10 Oct 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sara J Dent Acosta

10 Oct 2014
21 CFR 123.6(d)

Signed and dated

Cited by Sara J Dent Acosta

10 Oct 2014
21 CFR 123.9(a)

Records entries - timing

Cited by Sara J Dent Acosta

10 Oct 2014
21 CFR 123.11(b)

Sanitation monitoring

Cited by Sara J Dent Acosta

10 Oct 2014
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Sara J Dent Acosta

Inspected site

PSPacific Shellfish, IncSan Diego, United States

Inspection team

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 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x
n/aCited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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