Third-party GMP certification to remove firms from import detention usually involves minor violations.
This article was originally published in The Gray Sheet
Executive SummaryTHIRD-PARTY GMP CERTIFICATION OF FOREIGN DEVICE MANUFACTURERS to gain removal from FDA's import detention list is possible when the certification provides adequate assurance of compliance with good manufacturing practice requirements, FDAers say. Under an informal policy, FDA's Center for Devices and Radiological Health will on occasion remove a company from import detention solely on the basis of the third-party certification of GMP compliance, without a follow-up audit by the agency.
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