Form 483

Pacific American Fish Co. Form 483, 2017-09-13

FDA issued a Form 483 to Pacific American Fish Co. on 2017-09-13 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Pacific American Fish Co. · Vernon, United States · Issued September 13, 2017

Overview

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

13 Sep 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Alexandra B Pitkin, Herminio C Francisco

13 Sep 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Alexandra B Pitkin, Herminio C Francisco

13 Sep 2017
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Alexandra B Pitkin, Herminio C Francisco

13 Sep 2017
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Alexandra B Pitkin, Herminio C Francisco

13 Sep 2017
21 CFR 123.8(a)(3)(iii)

Verification - record review - calibration

Cited by Alexandra B Pitkin, Herminio C Francisco

Inspected site

PAPacific American Fish Co.Vernon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(iii)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 5 observations

The source PDF and 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