Atlas

Form 483

Pacific Hi - Tak, Inc Form 483, 2015-09-02

FDA issued a Form 483 to Pacific Hi - Tak, Inc on 2015-09-02 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Pacific Hi - Tak, Inc · Honolulu, United States · Issued September 2, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

2 Sep 2015
21 CFR 123.6(b)

HACCP plan implementation

Cited by Stuart Kim

2 Sep 2015
21 CFR 123.9(a)

Records - content

Cited by Stuart Kim

Inspected site

PHPacific Hi - Tak, IncHonolulu, United States

Inspection team

SKStuart Kim

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 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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