FDA 483 - CGG Medical Inc - July 16, 2025

CGG Medical Inc, an HCT/Ps storage and distribution facility in Pensacola, FL, received a Form 483 with two observations. The inspection revealed that core CGTP procedures were not reviewed and approved, and the firm lacked standard operating procedures for cleaning and sanitizing. Additionally, acceptable temperature limits for HCT/Ps storage were not established to prevent the growth of infectious agents.