FDA 483 - Life Sciences Vandalia - September 06, 2024

An FDA inspection of Life Sciences Vandalia in Dayton, OH, revealed significant deficiencies in their quality system for manufacturing implantable devices. Observations included inadequate maintenance of complaint files, insufficient documentation of corrective and preventive actions, and a lack of proper evaluation and documentation for out-of-calibration equipment. These issues indicate a potential impact on product quality and patient safety.