FDA Inspection
Alpha TeknikoAlpha Tekniko – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns Alpha Tekniko, with an inspection on December 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9577b29b-6da5-424b-85fb-b3ec8210a765
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034999
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alpha Tekniko
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2026 | NAI | Postmarket Assurance: Devices | |
| June 22, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alpha Tekniko
- FDA Inspection 1310970 - 2026-03-27
- FDA Inspection 1174382 - 2022-06-22
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