FDA 483 - Martin E. Gutierrez - November 20, 2024

An FDA inspection of Martin E. Gutierrez, a clinical investigator in Hackensack, NJ, revealed significant issues with the conduct of investigations and the accuracy of subject records. The firm failed to report numerous adverse events in accordance with investigational plans and did not maintain accurate case histories, including incorrect adverse event entries. These findings indicate serious deficiencies in clinical trial oversight and data integrity.