Atlas

Form 483

Warabeya USA Inc Form 483, 2016-10-25

FDA issued a Form 483 to Warabeya USA Inc on 2016-10-25 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Warabeya USA Inc · Waipahu, United States · Issued October 25, 2016

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

25 Oct 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Lynn L Wong, Stuart Kim, John Cook

25 Oct 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Lynn L Wong, Stuart Kim, John Cook

25 Oct 2016
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Lynn L Wong, Stuart Kim, John Cook

25 Oct 2016
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Lynn L Wong, Stuart Kim, John Cook

Inspected site

WUWarabeya USA IncWaipahu, United States

Inspection team

LLLynn L Wong
SKStuart Kim
JCJohn Cook

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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