FDA 483 - Aesculap Implant Systems LLC - June 08, 2021

Aezculap Implant Systems LLC in Breinigsville, PA, was inspected by the FDA from June 7-8, 2021, resulting in one observation. The inspection found that the firm failed to document evaluations of out-of-calibration equipment and remedial actions. This indicates a lapse in quality system documentation for critical manufacturing equipment.