Swedish Devicemaker Slammed Over Documentation

The FDA found lax documentation and inadequate design transfer procedures at devicemaker ScandiDos during an inspection at the firm’s Uppsala, Sweden facility.

The company develops the Delta4 family of products, a treatment dose verification system. A 2018 release of the Delta Phantom, Delta SW and common firmware was distributed without the signatures for all listed participants, which conflicts with the firm’s standard operating procedures, the Form 483 said.

The FDA said the firm’s procedures don’t adequately address the documentation, evaluation, segregation and disposition of non-conforming material, because there was no documentation for acceptance or rejection of incoming product.