North Carolina Devicemaker Flagged for Numerous Slipups
The FDA hit medical equipment manufacturer Diamond Orthopedic with a Form 483 for multiple violations at its Charlotte, North Carolina facility, including deficient supplier contracts and poor quality oversight.
During a March 25-April 5 inspection, the FDA investigator noted 11 observations. For example, the firm neglected to determine if a complaint about a device failure warranted reporting to the agency as an adverse event — and its complaint record didn’t justify the decision not to submit an MDR.
“The medical device investigation report does not record how the patient’s care was affected and it does not include comments from the doctor or medical professional that the incident was not a reportable event,” the agency said.