# FDA 483 - QView Medical, Inc. - December 10, 2021

Source: https://www.keypedia.com/records/483/qview-medical-inc/4715ba84-3e91-4c44-9596-cefa8d053ff4

> FDA 483 for QView Medical, Inc. on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QView Medical, Inc.
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of QView Medical, Inc., a medical device manufacturer in Los Altos, CA, revealed significant deficiencies across its quality system. The firm was cited for inadequate procedures and documentation concerning software validation, corrective and preventive actions, design review, device history records, and internal quality audits. These findings indicate a systemic lack of adherence to established quality system requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/qview-medical-inc/9c450d95-9e69-4619-9613-ce6e4b433459

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