FDA 483 - Milton Hom, OD - September 03, 2021

An FDA inspection of Milton M. Hom, O.D., Clinical Investigator in Azusa, CA, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan by enrolling subjects who met exclusion criteria and exhibited improper documentation of informed consent. Additionally, the inspection found inadequate maintenance of case histories and source documents, indicating a lack of proper record-keeping practices.