FDA 483 - Titan Implants, Inc - February 20, 2025

An FDA inspection of Titan Implants, Inc. in Bergenfield, NJ, a manufacturer of implants, revealed two significant quality system deficiencies. The firm failed to adequately document corrective and preventive actions, a repeat finding from a previous inspection. Additionally, the company did not properly establish requirements for suppliers and consultants, including review of purchasing documents and continuous monitoring of quality performance.