FDA Inspection
International Medical Devices, IncInternational Medical Devices, Inc – FDA Inspection, Jul 20, 2023
Record Details
This FDA Inspection record concerns International Medical Devices, Inc, with an inspection on July 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd941b97-f1e1-4f51-8d06-cc81795c74d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210674
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of International Medical Devices, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for International Medical Devices, Inc
- FDA Inspection 967743 - 2016-03-15
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