FDA Inspection
Hoya Corporation - Pentax Life DivisionHoya Corporation - Pentax Life Division – FDA Inspection, Apr 21, 2015
Record Details
This FDA Inspection record concerns Hoya Corporation - Pentax Life Division, with an inspection on April 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 21, 2015
- Product Type
- Devices
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ID · a75fb9ef-1742-4ce9-ae14-8d1d90d7281c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 925512
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Hoya Corporation - Pentax Life Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2023 | Not classified | Office of Inspections and Investigations | |
| September 7, 2018 | Not classified | Office of Inspections and Investigations | |
| July 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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