Contract Manufacturer Fails to Validate Equipment, Document Complaints

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. The agency found no analysis of processes, work operations, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data.

The investigators reviewed at least 13 customer complaints and all 13 were missing documentation of device history record reviews or dispositions, and none were finalized with signatures and dates of reviews and closures. Four complaints failed to specify the product associated with the complaint.

The firm had not established a device master record for manufacturing patient-specific Class II dental abutment medical devices and device history records were not established, the 483 said.

Read the Custom Milling Center Form 483 here: www.fdanews.com/11-07-19-custommillingcenterinc483.pdf.