Here’s what you should know.
1. SGS United Kingdom Limited issued the suspension.
2. GI Dynamics CEO and President Scott Schorer said in a release the suspension is not related to EndoBarrier’s safety and efficacy.
3. Mr. Schorer said the suspension does not require a recall.
“We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS,” he said.
4. EndoBarrier hired a chief compliance officer with experience in the area to address the nonconformance issues SGS identified.
5. EndoBarrier has shipped a “sufficient” inventory to physicians to maintain supply levels through the suspension.
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