FDA Inspection
Advalight ApSAdvalight ApS – FDA Inspection, Apr 11, 2024
Record Details
This FDA Inspection record concerns Advalight ApS, with an inspection on April 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d6645aab-d9ba-420f-be63-e4932f45ef8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235694
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Advalight ApS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| November 26, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Advalight ApS
- FDA Inspection 1049187 - 2018-04-19
- FDA Inspection 950736 - 2015-11-26
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