# FDA 483 - Novutech LLC - February 06, 2025

Source: https://www.keypedia.com/records/483/novutech-llc/e0d58fbf-16ad-4dfb-96df-aee4f8612168

> FDA 483 for Novutech LLC on February 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novutech LLC
- Inspection Date: 2025-02-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Novutech LLC, an HCT/P distributor in Doral, FL, received a Form 483 with five observations during an FDA inspection. The firm failed to establish and maintain adequate procedures for the storage, receipt, distribution, return, and tracking of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Additionally, the company lacked proper procedures for handling complaints related to core current good tissue practice requirements.

## Related Documents

- [483 - 2025-02-06](https://www.keypedia.com/records/483/novutech-llc/a1024894-f7dd-4ae1-af31-ca9f044abab4)

## Related Officers

- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)

Company: https://www.keypedia.com/companies/novutech-llc/ee14a283-5e90-49d6-b665-30094b416bbe

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