FDA Inspection
HOYA Corporation PENTAX Miyagi FactoryHOYA Corporation PENTAX Miyagi Factory – FDA Inspection, Apr 24, 2015
Record Details
This FDA Inspection record concerns HOYA Corporation PENTAX Miyagi Factory, with an inspection on April 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 24, 2015
- Product Type
- Devices
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ID · 4b45504d-40d1-413a-95e6-854ba344f150
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926494
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of HOYA Corporation PENTAX Miyagi Factory
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2023 | Not classified | Office of Inspections and Investigations | |
| September 4, 2018 | Not classified | Office of Inspections and Investigations | |
| November 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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