MONDAY, June 25 (HealthDay News) -- Shelhigh, Inc., of Union, N.J., has agreed to a court order preventing the distribution of its implantable medical devices used in surgical procedures, notably heart surgery. The injunction is the outcome of an investigation by the U.S. Food and Drug Administration, which found that the company failed to comply with good manufacturing practice.
The manufacturer of pediatric heart valves and conduits, surgical patches, dural patches, arterial grafts and annuloplasty rings had all its products seized by U.S. Marshals in April this year because of the risk of non-sterility.
Before it can resume business the company must hire independent experts to ensure its facilities meet FDA requirements. Shelhigh will not be able to distribute devices until the FDA has conducted a phased approval plan to ensure compliance with FDA law and it must be independently audited at least once a year after it is allowed to resume manufacturing.
"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," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, in a statement.
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