FDA Inspection
Toray Industries, Inc. - Okazaki PlantToray Industries, Inc. - Okazaki Plant – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Toray Industries, Inc. - Okazaki Plant, with an inspection on September 25, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 25, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 6659f600-ea3e-43cc-8c60-7d737c158bb8
Inspection Facts
- Inspection number
- 1338148
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Toray Industries, Inc. - Okazaki Plant
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 21, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Toray Industries, Inc. - Okazaki Plant
- FDA Inspection 1052325 - 2018-04-06
- FDA Inspection 1034855 - 2017-07-21
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.