FDA 483 - Arch Medical Solutions - Elkhart - December 18, 2024

Arch Medical Solutions - Elkhart received a Form FDA 483 with four observations related to deficiencies in their quality system. The inspection revealed issues with controlling nonconforming product, inadequate rationale for "use-as-is" dispositions, and a failure to evaluate changes to a validated process. Additionally, the firm's complaint handling procedures were found to be inadequate, with undocumented investigations and inconsistent documentation methods.