FDA 483 - Dental Implant Technologies, Inc - August 22, 2025

An FDA inspection of Dental Implant Technologies, Inc. in Scottsdale, AZ, conducted from August 21-22, 2025, revealed a significant lapse in their quality program. The firm failed to document appropriate corrective actions for a critical temperature monitoring device used for HCT/Ps, which was inoperable for an extended period. This indicates a serious deficiency in ensuring the quality and safety of stored human cells, tissues, and cellular and tissue-based products.