After uncovering “significant deficiencies” in the company’s manufacturing processes, FDA seized all implantable devices made by Union, NJ, device maker Shelhigh. The agency said the deficiencies concern the sterility of the products, which include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts.
It appears that FDA has known about the violations since last fall, when it performed a facility inspection that uncovered violations. Since that inspection, FDA held meetings with the company at which it was informed that disciplinary action would be taken if it didn’t clean up the deficiencies. FDA said yesterday in an announcement that it also sent two warning letters to Shelhigh.
Shelhigh was found guilty of the following: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.
FDA has ordered physicians to consider using alternative devices and to monitor patients already implanted with Shelhigh products, and told patients who think they may have received a Shelhigh device during surgery to contact their doctors.