# FDA 483 - Next Science, LLC - September 05, 2024

Source: https://www.keypedia.com/records/483/next-science-llc/ee7fa8be-d501-4478-ab0f-38873a761d3f

> FDA 483 for Next Science, LLC on September 05, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Next Science, LLC
- Inspection Date: 2024-09-05
- Product Type: device
- Office Name: Florida District Office
- Summary: Next Science, LLC, a medical device manufacturer in Jacksonville, FL, was cited for ten observations primarily related to inadequate design controls, risk analysis, and complaint handling for its surgical solutions and wound gels. The firm failed to validate product claims, investigate adverse events like excessive bleeding, and ensure proper management of complaints and labeling changes, indicating significant deficiencies in its quality management system.

## Related Documents

- [483 - 2019-10-25](https://www.keypedia.com/records/483/next-science-llc/ca852c3a-16cb-4384-9bf0-41f28c45e921)
- [WARNING_LETTER - 2024-09-05](https://www.keypedia.com/records/warning_letter/next-science-llc/1af4d22c-4c37-4725-8af9-9d8df87a372d)

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.keypedia.com/companies/next-science-llc/85588e89-3b46-46a8-9278-095498239b60

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9