Numerous complaints for unsealed cautery tip cleaning surgical devices were not documented as complaints, and validation procedures were found to be lacking at Xodus Medical during an inspection of its New Kensington, Pennsylvania plant.

The maker of surgical equipment failed to review, evaluate and revalidate its production process for sealing when changes and process deviations occurred. When products were returned due to failure to meet their specifications, these complaints were not reviewed, evaluated or investigated, the FDA said.

The agency investigators said the firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specifications.” Equipment used in production was causing unsealed packaging of sterile products, and lots were not inspected before being shipped and released, the agency said.