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FDA Issues Cepheid Warning Letter for GMP Violations at Swedish Site

NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued a warning letter to Cepheid's European manufacturing and R&D site in Solna, Sweden, informing the firm that its production of Xpert Norovirus assays at the site does not conform to good manufacturing practice requirements.

The FDA published the warning letter online this week. The agency sent the letter to Cepheid in July, noting that a March FDA inspection of the Swedish facility revealed that the Xpert Norovirus tests "are adulterated … in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements" of the Quality System regulation in the Code of Federal Regulations.

The FDA also noted that an April response letter from a Cepheid employee addressing the investigator's observations was not adequate in that it "did not provide documentation or evidence of the implementation of corrective actions" such as a revised design control feature to address an identified deficiency in defining pre-production design changes to the assay; or establishing procedures to ensure that all purchased or otherwise received product[s] and services conform to specific requirements as required by the CFR.

Finally, the FDA's letter noted that "US federal agencies may be advised of the issuance of warning letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected."

In an email to GenomeWeb, Scott Campbell, vice president of clinical affairs and chief regulatory officer for Cepheid, said that the company is "in ongoing discussions with the FDA regarding the questions raised following their inspection of our Sweden facility back in March," and that Cepheid "has embraced the opportunity to further strengthen our procedures and documentation."

Campbell also said that "there is absolutely no impact on Xpert customers as we move to resolve these questions quickly and completely."

Cepheid's Xpert Norovirus is a qualitative in vitro diagnostic test that runs on the company's GeneXpert platform and identifies and differentiates norovirus genogroup I (GI) and genogroup II (GII). The company received FDA clearance for the assay in December.