Shelhigh To Stop Manufacturing, Distributing Medical Devices
An injunction entered yesterday in the U.S. District Court forbids the Union, N.J. company Shelhigh from distributing the medical devices it manufactures until the company’s facilities, manufacturing methods, and quality control processes meet relevant FDA standards.
Concerns about Lack of Sterile Conditions
Shelhigh agreed to the injunction. The company’s main products are implantable pediatric heart valves and conduits, annuloplasty rings, surgical patches, dural patches, and arterial grafts. Federal agents seized all of the finished products at Shelhigh’s manufacturing facility in April 2007, based on concerns about non-sterility conditions at the facility.
As Daniel Schultz, the director of the FDA Center for Devices and Radiological Health, noted, “It is critical that companies comply with FDA’s manufacturing rules so that medical devices, especially the kind of implantable devices made by Shelhigh, are safe and effective.”
Outside Inspectors to Suggest Changes
The injunction includes a consent order requiring that Shelhigh hire independent expert consultants as a next step. The consultants’ job is to inspect the Shelhigh facility and indicate changes that need to be made to bring the company into compliance with the FDA’s CGMP (Current Good Manufacturing Practice) and QS (Quality Systems) regulations for medical devices and MDR (Medical Device Reporting) requirements.
When the changes have been made and the outside consultants have certified that the company is in compliance, Shelhigh may resume manufacturing, but not distributing, its medical device products, according to the court order. The manufacturing will resume in phases. Shelhigh must then have independent auditors inspect its facilities at least once a year, with the results of the inspections to be given to the FDA.
No Recall of Products on the Market
However, the FDA has not invoked the federal Food, Drug, and Cosmetic Act to require Shelhigh to recall the medical devices already on the market and in the possession of hospitals and clinics. Shelhigh has not implemented a recall on its own.