Contract Manufacturer Rapped for Equipment Validation, Complaint Documentation

Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility.

The contract manufacturer failed to validate its process for equipment used in manufacturing Class II dental devices, and the documentation didn’t include all requirements defined in the process validation procedures.

Numerous documentation lapses were observed for corrective and preventive action procedures, including missing signatures and risk assessments of CAPA actions.