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Orion schedules reinspection of Finnish facility to remove products from import detention.

This article was originally published in The Gray Sheet

Executive Summary

ORION DIAGNOSTICA SHIPMENT OF 13 SEX HORMONE BINDING GLOBULIN RIA KITS violates an Aug. 14 import detention placed on the company, FDA says in an Oct. 30 warning letter to the firm. Orion has been barred from importing in vitro diagnostics manufactured at its Oulu, Finland facility since receiving a warning letter from FDA on May 31. The letter cited Orion for violations of good manufacturing practice regs related to production of SHBG radioimmunoassay kits and procollagen, telopeptide bone and tissue markers ("The Gray Sheet" July 1, I&W-8).
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