483
Novutech LLCFDA 483 - Novutech LLC - February 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · e0d58fbf-16ad-4dfb-96df-aee4f8612168