SafetyFix Medical Technologies Cited for Device Record Shortcomings
The FDA issued the St. Louis, Mo., device manufacturer a Form 483 for device record issues and procedural failures following a November inspection.
The investigator observed that the firm’s device master record (DMR) for fixation screws did not define certain specifications, including packaging, labeling, acceptance criteria and quality assurance.
The device history record for the same product also did not have documentation of primary labeling, and the agency said the facility had shipped loose, unlabeled fixation screws since 2016.
The firm also had design validation problems. It lacked objective evidence to show that its easy out screw design was validated using initial production units, lots, batches or their equivalents. The risk analysis was also inadequately documented, as its product design failure modes and effects analysis was unsigned, undated and only in a draft form.
In addition, the firm did not have adequate requirements that must be met by its suppliers. It accepted a contract manufacturer without confirming the supplier could meet product specifications and it lacked documentation to show that a consulting firm it employed was evaluated and approved as a supplier of services.
The firm also lacked written medical device reporting procedures.