FDA 483 - Novutech LLC - February 06, 2025

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.