# FDA 483 - Tonica Elektronik A/S - December 07, 2017

Source: https://www.globalkeysolutions.net/records/483/tonica-elektronik-as/2633aa26-7464-4d58-9e3b-cb534a15c750

> FDA 483 for Tonica Elektronik A/S on December 07, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tonica Elektronik A/S
- Inspection Date: 2017-12-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Tonica Elektronik A/S, a medical device manufacturer in Farum, Denmark, was cited for significant deficiencies in its quality system during an FDA inspection. The observations primarily concern inadequate procedures and investigations related to complaint handling, design control, quality data analysis, and rework of nonconforming products. These issues indicate a lack of robust controls to ensure device quality and patient safety.

## 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)
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## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd