Ohio Company Hit for Missing Procedures
The FDA cited devicemaker Smart Tools Plus for lacking various procedures at its facility in North Royalton, Ohio.
The agency’s March 18-20 inspection revealed that the company did not have procedures to obtain, investigate or manage medical device complaints. It also lacked procedures for identifying and analyzing quality data for potential corrective and preventive actions.
In addition, the investigator found that the company lacked procedures in place for identifying, isolating or managing non-conforming products.