FDA 483 - Novutech LLC - February 06, 2025

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.