Form 483

New Day Fisheries Inc Form 483, 2012-06-08

FDA issued a Form 483 to New Day Fisheries Inc on 2012-06-08 with 9 public-safe observations.

483· Form 483 issued9 observations

New Day Fisheries Inc · Port Townsend, United States · Issued June 8, 2012

Overview

  • 9 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.

8 Jun 2012
21 CFR 110.20(b)(6)

Adequate ventilation

Cited by Jinkee M Vila Binayug, Mai Hang

8 Jun 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Jinkee M Vila Binayug, Mai Hang

8 Jun 2012
21 CFR 123.6(c)(2)

Critical control points

Cited by Jinkee M Vila Binayug, Mai Hang

8 Jun 2012
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Jinkee M Vila Binayug, Mai Hang

8 Jun 2012
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Jinkee M Vila Binayug, Mai Hang

Inspected site

NDNew Day Fisheries IncPort Townsend, United States

Inspection team

JMJinkee M Vila Binayug

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 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)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 9 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