Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
The Chinese Department of Health has issued a field safety notice for Cordis’ S.M.A.R.T. Control Nitinol stent system due to a sterility breach in all pouches of the stent system. The defect was detected during in-house testing on non-production product as part of a development project.