Atlas

Form 483

YAMAHARU COMPANY Form 483, 2019-11-01

FDA issued a Form 483 to YAMAHARU COMPANY on 2019-11-01 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

YAMAHARU COMPANY · Koto, Japan · Issued November 1, 2019

Overview

  • 4 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.

1 Nov 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Derek S Dealy

1 Nov 2019
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Derek S Dealy

1 Nov 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Derek S Dealy

1 Nov 2019
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Derek S Dealy

Inspected site

YCYAMAHARU COMPANYKoto, Japan

Inspection team

DSDerek S Dealy

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)(5)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