FDA Inspection
Diatron MI PlcDiatron MI Plc – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Diatron MI Plc, with an inspection on May 19, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 3a18fb13-b0dd-4329-943d-b7cd1635a6ca
Inspection Facts
- Inspection number
- 1012057
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Diatron MI Plc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2025 | Not classified | Office of Inspections and Investigations | |
| February 9, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Diatron MI Plc
- FDA Inspection 1301970 - 2025-11-20
- FDA Inspection 1197444 - 2023-02-09
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