The FDA has hit Cepheid with a warning letter for not taking corrective actions to deal with good manufacturing practice deviations at its Solna, Sweden facility.
During a March 30 to 31 inspection, FDA investigators found that the company did not provide documentation or evidence of the implementation of corrective actions regarding design changes to the Xpert Norovirus test, including a revised design control procedure to address the identified deficiency. The company also did not provide evidence that employees were trained on the revised design change procedures.
The FDA originally detailed the findings in a Form 483, but deemed several of the firm’s responses inadequate, according to the July 23 letter. Cepheid’s CAPA procedures were also lacking because they didn’t require verification or validation of the CAPA to ensure it doesn’t adversely affect the finished device.
Scott Campbell, vice president of clinical affairs and chief regulatory officer at Cepheid, says the company is in discussions with the FDA regarding questions raised following the inspection. He adds that there is no impact on customers as the company moves to resolve these questions quickly and completely.