# FDA 483 - SonoCine Inc. - August 16, 2019

Source: https://www.keypedia.com/records/483/sonocine-inc/22377474-39d8-4f29-bdbd-b2bc46dd161f

> FDA 483 for SonoCine Inc. on August 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SonoCine Inc.
- Inspection Date: 2019-08-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Sonotine Inc. in Reno, NV, a medical device manufacturer, revealed significant deficiencies across three observations. The firm failed to adequately control non-conforming products, specifically an unapproved investigational device distributed outside of its clinical study. Additionally, Sonotine Inc. lacked proper supplier management procedures and conducted a clinical investigation without meeting abbreviated requirements for investigational device exemptions, including the absence of IRB involvement and informed consent.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/sonocine-inc/2b65ee06-f655-4916-8561-88c9d6a698f7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b