FDA 483 - Zoila M. Alen, M.D. - February 09, 2024

Zoila M. Alen, MD, Clinical Investigator, was cited for significant deficiencies during an FDA inspection regarding the conduct of clinical studies. The inspection revealed failures to adhere to investigational plans, including enrolling subjects who did not meet inclusion criteria and improper dosing. Additionally, the firm failed to maintain accurate case histories, with issues such as unconfirmed data changes, duplicate source documents, and discrepancies in GCP training certificates.