# FDA 483 - NEURELEC - June 02, 2022

Source: https://www.globalkeysolutions.net/records/483/neurelec/9e5c4a1f-ba0c-4c94-996d-bf9287452b54

> FDA 483 for NEURELEC on June 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEURELEC
- Inspection Date: 2022-06-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Oticon Medical, a manufacturer of Cochlear Implant devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling, including timely processing, documentation, and Medical Device Report (MDR) reportability evaluations. Additionally, corrective and preventive action activities, particularly investigations into device failures leading to recalls, were not properly documented.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.globalkeysolutions.net/companies/neurelec/7e121ac2-8de5-4034-b39b-f4768d711b5d

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