# FDA 483 - Cochlear Americas Inc. - February 22, 2018

Source: https://www.keypedia.com/records/483/cochlear-americas-inc/e1d96993-d0f1-4a88-8746-4266a4878897

> FDA 483 for Cochlear Americas Inc. on February 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cochlear Americas Inc.
- Inspection Date: 2018-02-22
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Cochlear Americas Inc. in Centennial, CO, acting as a sponsor for an investigational study, revealed significant non-compliance. The firm failed to adhere to investigational plans, regulatory requirements, and IRB/FDA approval conditions, particularly concerning informed consent processes. Additionally, issues were noted with the accuracy and completeness of adverse device effect reports and the overall inadequacy of monitoring activities for the clinical study.

## Related Documents

- [483 - 2021-10-21](https://www.keypedia.com/records/483/cochlear-americas-inc/097e786d-e3b6-40a3-b4ff-93e96aba01a8)

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/cochlear-americas-inc/87342f6e-3f58-4bea-b41f-0ab2088226df

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face