# FDA 483 - KeriCure Inc. - June 11, 2026

Source: https://www.keypedia.com/records/483/kericure-inc/ad0ef996-24a4-4707-89d8-3bf4b3a61ae4

> FDA 483 for KeriCure Inc. on June 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KeriCure Inc.
- Inspection Date: 2026-06-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Kericure Inc., a medical device manufacturer in Maitland, FL, revealed significant deficiencies in their quality management system. Observations included inadequate risk management records, unapproved process validation reports, and outdated quality system documentation that failed to comply with current regulatory requirements. Additionally, the firm's complaint handling procedures were found to be insufficient.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

Company: https://www.keypedia.com/companies/kericure-inc/58daf035-6ff3-4754-a082-6093afaf1b1b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6