# FDA 483 - Resonea, Inc. - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/resonea-inc/23132ad7-00af-4c25-9513-14c9278e1d48

> FDA 483 for Resonea, Inc. on December 09, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Resonea, Inc.
- Inspection Date: 2022-12-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Resonea, Inc., a medical device manufacturer in Scottsdale, AZ, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of procedures for non-conforming product control and inadequate supplier controls for contractors and consultants. Additionally, the firm failed to conduct required annual internal quality audits and management reviews of its quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/resonea-inc/ace58665-57cf-49cf-ab2a-0a7b955dddf3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6