FDA 483 - 3D SYSTEMS - LAYERWISE - June 15, 2023

During an inspection conducted from June 12-15, 2023, the FDA issued a Form FDA-483 to 3D SYSTEMS - LAYERWISE, a medical device manufacturer based in Leuven, Belgium. The inspection identified three significant observations indicating deviations from quality system requirements. First, the company's procedures for managing customer complaints were inadequate. Deficiencies included inconsistent documentation of complaint receipt dates, a lack of defined timelines for processing, and failure to evaluate complaints for potential Medical Device Reportable events. Examples showed delays in recording and closing complaint records.

Second, the firm's corrective and preventive action (CAPA) procedures were found to be insufficient. Issues included inaccurate recording of implemented changes, inadequate documentation of associated training, and incomplete data for effectiveness checks. A notable instance involved a spinal cage batch produced with an incorrect file, mislabeled, and released to the U.S. market, where CAPA documentation was found lacking.

Finally, procedures for controlling nonconforming products were inadequate. In-process nonconforming devices were not consistently identified, and the disposition of such products, including those processed 'as is,' was not accurately documented.

These observations highlight the company's need to enhance its quality management system to ensure compliance with medical device regulations. 3D SYSTEMS - LAYERWISE has committed to addressing all noted observations and implementing comprehensive corrective actions to ensure robust complaint handling, effective CAPA processes, and proper control of nonconforming materials.