FDA 483 - Deborah A. Goss, M.D. - March 17, 2025

An FDA inspection of Deborah A. Goss, M.D. in Hackensack, NJ, revealed significant issues in the conduct and documentation of clinical investigations. The firm failed to adhere to its investigational plan, maintain complete records, and ensure the accuracy of subject case histories. Additionally, adverse device effects were not fully recorded or reported to the sponsor, indicating a lack of compliance with regulatory requirements for clinical trials.