Company
HungaryDiatron MI Plc, Budapest, Hungary – FDA Inspections
Inspection records and compliance data for Diatron MI Plc in Budapest. 3 FDA inspections on record, 2 Form 483s, last inspected November 20, 2025.
Company Profile
This profile covers Diatron MI Plc based in Budapest, Hungary.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 19, 2017. Last inspected November 20, 2025.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 20, 2025 | Not classified | Medical Devices & Rad Health | 1301970 |
| February 9, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1197444 |
| May 19, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1012057 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Diatron MI Plc
FEI Number
3009297077
Address
Tablas Utca 39, Budapest, Hungary
Country
Hungary
ID: 99657ad1-d752-4e22-b69e-9d36748d50d5