# FDA 483 - Novutech LLC - February 06, 2025

Source: https://www.globalkeysolutions.net/records/483/novutech-llc/a1024894-f7dd-4ae1-af31-ca9f044abab4

> 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: Florida District Office
- Summary: Novutech LLC, an HCT/P Distributor in Doral, FL, was cited for multiple deficiencies during an FDA inspection. The firm failed to establish and maintain adequate procedures for critical operations including HCT/P storage temperature recording, receipt and distribution, handling of returned products, complaint management, and product tracking. These issues indicate significant gaps in their current good tissue practice compliance.

## Related Officers

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

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

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