# FDA 483 - Venus Concept Inc - January 16, 2020

Source: https://www.keypedia.com/records/483/venus-concept-inc/212a4461-1f71-4049-afc2-7a31dd82f644

> FDA 483 for Venus Concept Inc on January 16, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Venus Concept Inc
- Inspection Date: 2020-01-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Venus Concept Inc, a medical device manufacturer in San Jose, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document and timely process corrective and preventive actions (CAPAs), with a majority of reviewed CAPAs showing issues. Additionally, complaint files were not properly maintained, exhibiting problems with timely reporting, thorough investigation, and accurate malfunction evaluations.

## Related Documents

- [483 - 2020-01-16](https://www.keypedia.com/records/483/venus-concept-inc/1170e7f4-205f-4f6b-95f5-a454936ffc77)

## Related Officers

- [Consumer Safety Officer/Investigator at FDA](https://www.keypedia.com/people/marcia-g-evans/2e20a31d-0267-4040-b1a1-c0bec23b964b)

Company: https://www.keypedia.com/companies/venus-concept-inc/f18a5dee-b638-449f-9669-a405d272e789

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