FDA Inspection
Kaneka CorporationKaneka Corporation – FDA Inspection, Feb 6, 2025
Record Details
This FDA Inspection record concerns Kaneka Corporation, with an inspection on February 6, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 9358167c-d586-4ba9-89ee-781a18a035cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260082
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kaneka Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kaneka Corporation
- FDA Inspection 1012619 - 2017-04-19
- FDA Inspection 962212 - 2016-03-03
- FDA Inspection 800241 - 2012-09-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.