FDA Inspection
Diatron MI PlcDiatron MI Plc – FDA Inspection, Feb 9, 2023
Record Details
This FDA Inspection record concerns Diatron MI Plc, with an inspection on February 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e801d798-ba38-4dab-a42e-b48d02add113
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197444
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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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 | |
| May 19, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for Diatron MI Plc
- FDA Inspection 1301970 - 2025-11-20
- FDA Inspection 1012057 - 2017-05-19
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