# FDA 483 - BODY VISION MEDICAL - July 28, 2022

Source: https://www.keypedia.com/records/483/body-vision-medical/f7b83002-e7af-4331-8f20-49c1bead53aa

> FDA 483 for BODY VISION MEDICAL on July 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BODY VISION MEDICAL
- Inspection Date: 2022-07-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BODY VISION MEDICAL, an Israeli medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The firm's procedures for medical device reporting, complaint handling, servicing, process validation, design change, rework of nonconforming product, and CAPA were found to be inadequate. These issues indicate a systemic lack of control over critical quality processes for their Lung Vision System and Tool.

## Related Officers

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

Company: https://www.keypedia.com/companies/body-vision-medical/1b79dcb2-8d4a-4b6d-8901-73c4e7e31a8f

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