BAYER PLASMA PLANTS' STERILITY FAILURE INVESTIGATIONS CITED BY FDA in a warning letter sent to the company Jan. 30. The letter stemmed from an Aug. 18-Oct. 14 inspection at Bayer's Clayton, N.C. facility and a Dec. 1-11 inspection at its Berkeley, Calif. facility. "Investigations of product sterility failures at Clayton do not extend to other products or processes which could be effected by the failure," the letter states, and standard operating procedures do not lay out investigation procedures in proper detail. At both facilities, the "sterilization validation program fails to demonstrate that equipment and components used in aseptic manufacturing are sterilized" to an appropriate sterility assurance level and microbial challenge level, the letter adds.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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