Shelhigh Consent Agreement Stops Short of Recall

Shelhigh has agreed to stop distributing its implantable devices, roughly two months after FDA seized products made at the company’s Union, NJ, manufacturing facility. Under a court order signed last Friday, Shelhigh is required to hire independent consultants to inspect its facility and certify to FDA that everything is up to snuff. The order, though, stopped short of demanding a recall.

In April, FDA announced that it had uncovered “significant deficiencies” in Shelhigh’s manufacturing processes, expressing concern about the sterility of its devices, which include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The agency seized what it could find at the Union facility, and ordered physicians to consider using alternative devices and to monitor patients already implanted with Shelhigh products.

Two weeks after the seizure, FDA asked Shelhigh to voluntarily recall its devices, but the company did not comply. At the time, Shelhigh’s marketing director, Douglas Goldman, told The Star Ledger that FDA has “no information to justify any action with regard to our devices,” adding, “Our products are safe and effective and have never been demonstrated to be unsterile.”

In the end, though — in lieu of a potentially lengthy court process — Shelhigh and FDA came to terms. The order signed last week, however, does not require Shelhigh to recall its devices, but rather, only to stop distributing them until FDA has approved the company’s plan for bringing its seized products and manufacturing processes into compliance. It’s at that point that Shelhigh will be allowed to resume manufacturing. Once that happens, the company is required to hire an independent auditor, who will report back to FDA, to inspect its facility at least once a year.

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