US Food and Drug Administration issues warning letter to Cepheid's Swedish site
The US Food and Drug Administration has issued a warning letter to Cepheid's European manufacturing and R&D site in Solna, Sweden. FDA issued the warning letter because the site does not conform to good manufacturing practice requirements.
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.
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," 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."