FDA Inspection
Mauna Kea TechnologiesMauna Kea Technologies – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Mauna Kea Technologies, with an inspection on May 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5f3cf109-b885-402a-aee4-6374ce63eb64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053547
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Mauna Kea Technologies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 4, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mauna Kea Technologies
- FDA Inspection 1247593 - 2024-07-04
- FDA Inspection 865535 - 2014-01-30
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