FDA 483 - Team1 LLC - October 28, 2024

TeamI LLC, a human tissue distributor in Jacksonville, FL, received a Form 483 with three observations during an FDA inspection. The firm was cited for failing to review and revise procedures to reflect current operations and ensure approval, not periodically reviewing recorded storage temperatures, and lacking established and documented procedures for facility cleaning and sanitation. These findings indicate significant deficiencies in the firm's quality system and record-keeping practices.