# FDA 483 - Tonica Elektronik A/S - March 27, 2025

Source: https://www.globalkeysolutions.net/records/483/tonica-elektronik-as/d2896b0e-210f-454e-afd4-1fd8f40327bb

> FDA 483 for Tonica Elektronik A/S on March 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tonica Elektronik A/S
- Inspection Date: 2025-03-27
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Tonica Elektronik A/S, a device manufacturer in Farum, Denmark, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in the firm's device history records and design validation processes. These issues specifically concerned the documentation of instructions for use and the confirmation of design changes for the MagVenture TMS Atlas Neuro Navigation system.

## Related Documents

- [WARNING_LETTER - 2012-08-02](https://www.globalkeysolutions.net/records/warning_letter/tonica-elektronik-as/55095435-e276-438f-84b8-b752bc0d4550)
- [483 - 2017-12-04](https://www.globalkeysolutions.net/records/483/tonica-elektronik-as/151eb01a-6ddc-41ad-9365-a4b3e1783a90)
- [483 - 2017-12-07](https://www.globalkeysolutions.net/records/483/tonica-elektronik-as/2633aa26-7464-4d58-9e3b-cb534a15c750)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/tonica-elektronik-as/26fcf27a-83e5-4df3-aa6d-620659e1448c

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8