FDA 483 - Aspen Surgical Products, Inc. - November 08, 2017

Aspen Surgical Products, Inc. in Caledonia, MI, received a Form FDA 483 with five observations related to its quality system for medical devices. The inspection revealed deficiencies in procedures for corrective and preventive actions, control of nonconforming product, design validation, and monitoring of validated process parameters. Additionally, the firm failed to document in-process inspection results.