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

An FDA inspection conducted on August 21-22, 2025, at Dental Implant Technologies, Inc. in Irvine, CA, identified a significant observation regarding the company’s quality program. The primary concern was the firm's failure to ensure appropriate corrective actions were taken and documented, particularly concerning core Current Good Tissue Practice (CGTP) requirements.Specifically, inspectors noted that the company did not document any corrective actions following the prolonged failure of a critical temperature monitoring device, identified as a "(b)(4) Temperature & Humidity Sensor," which is used to monitor Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) stored in the bone graft room. This device was inoperable from approximately June 8, 2023, until February 5, 2024. During this extensive period, the firm failed to record details such as the HCT/Ps affected, their disposition, the exact nature of the problem, or the specific corrective actions taken and their dates.This observation, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicates a lapse in maintaining robust quality system controls. To address this, Dental Implant Technologies, Inc. is expected to promptly implement and meticulously document comprehensive corrective and preventive actions. These actions must ensure that all quality system deviations, especially those impacting critical monitoring equipment and stored HCT/Ps, are thoroughly investigated, documented, and rectified to maintain product quality and regulatory compliance.