Atlas

Form 483

Kaneka Corporation Form 483, 2025-02-06

FDA issued a Form 483 to Kaneka Corporation on 2025-02-06 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Kaneka Corporation · Settsu, Japan · Issued February 6, 2025

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.

6 Feb 2025
21 CFR 820.198(d)

Evaluation, timeliness, identification

Cited by Dianiris C Ayala

6 Feb 2025
21 CFR 820.250(a)

Statistical techniques - Lack of or inadequate procedures

Cited by Dianiris C Ayala

Inspected site

KCKaneka CorporationSettsu, Japan

Inspection team

DCDianiris C Ayala

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(d)Cited across public-safe Form 483 observations1x
21 CFR 820.250(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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