FDA Inspection
Hoya Corporation - Pentax Life DivisionHoya Corporation - Pentax Life Division – FDA Inspection, Aug 10, 2023
Record Details
This FDA Inspection record concerns Hoya Corporation - Pentax Life Division, with an inspection on August 10, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- August 10, 2023
View Company Profile
ID · ab77c317-1682-464a-a3d4-f76e5003c39f
Inspection Facts
- Inspection number
- 1215013
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hoya Corporation - Pentax Life Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2018 | Not classified | Office of Inspections and Investigations | |
| April 21, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hoya Corporation - Pentax Life Division
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.