FDA 483 - Hardy Diagnostics - June 09, 2023

An FDA inspection of Hardy Diagnostics in Santa Maria, CA, resulted in a Form FDA 483 with three observations. The firm was cited for not adequately establishing procedures for accepting incoming raw materials, specifically donor sheep blood, before final sterility test results were received. Additionally, the inspection found deficiencies in the documentation of corrective and preventive actions, as well as a lack of documented personnel training.