Lack of Procedures Lands Arrowhead Dental 12-Item 483

Class II device manufacturer Arrowhead Dental was cited for failure to develop design control and medical device reporting procedures among other quality failures in a Form 483 issued following a December 2017 inspection of the firm’s Sandy, Utah facility.

The firm lacked design control procedures for sleep apnea devices it had been selling since April 2012, the 12-item 483 said. It also did not have a design history file for its Elastic Mandibular Advancement device, and it failed to address planning, inputs, design reviews, risk, or design verifications for design changes.

The inspector observed that Arrowhead didn’t develop written MDR procedures and it lacked approved procedures for handling and evaluating complaints for the Class II devices.

Also missing were CAPA procedures and procedures to ensure that equipment is routinely calibrated, inspected checked and maintained. The firm also lacked acceptance procedures for raw materials as well as procedures to control products that don’t conform to specifications.

In addition, Arrowhead had no device master record for documentation associated with specifications and manufacturing requirements. The facility also lacked written procedures for device history records, management reviews, quality audits or training.