FDA EIR - Valdepharm - April 27, 2015

An FDA inspection of Valdepharm in Val de Reuil, France, was conducted from April 20 to April 27, 2015. This was a pre-approval and Current Good Manufacturing Practice (cGMP) inspection for a sterile drug and active pharmaceutical ingredient (API) manufacturer, specifically for generic veterinary drugs. The inspection assessed the company's readiness for commercial operations, covering finished dosage drug systems (Quality, Facilities and Equipment, Materials, Production, and Laboratory Control) and API systems (Quality and Laboratory Control). The primary issue identified during the inspection was detailed in a one-item FDA 483: Inspectional Observations. It stated that the company's smoke studies, which evaluate airflow patterns in critical aseptic processing areas, were not conducted under dynamic conditions. This meant they failed to assess all potential interventions performed by personnel during an aseptic filling run. In response to this observation, Valdepharm's management committed to correcting the issue and indicated they would provide a formal response to the FDA within 15 business days. The inspection aimed to ensure compliance with regulatory standards for drug manufacturing ahead of product approval.