FDA Inspection
HOYA Corporation PENTAX Miyagi FactoryHOYA Corporation PENTAX Miyagi Factory – FDA Inspection, Nov 21, 2013
Record Details
This FDA Inspection record concerns HOYA Corporation PENTAX Miyagi Factory, with an inspection on November 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 21, 2013
- Product Type
- Devices
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ID · f6f72b63-9d67-4914-b3f7-69825b6459f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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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 | |
| April 24, 2015 | 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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