FDA Inspection
Tytek Medical IncTytek Medical Inc – FDA Inspection, Jun 21, 2023
Record Details
This FDA Inspection record concerns Tytek Medical Inc, with an inspection on June 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 896b454f-b41f-4386-be3a-44b59e3cf1dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210081
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(a)(1)Report of risk to health
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Other FDA inspections of Tytek Medical Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tytek Medical Inc
- FDA Inspection 1054584 - 2018-04-23
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