Cepheid Ab – FDA Warning Letter, Mar 31, 2015

On July 23, 2015, the FDA issued a Warning Letter to Cepheid Ab in Solna, Sweden, following an inspection from March 30-31, 2015. The inspection revealed that the firm's Xpert Norovirus devices were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as manufacturing methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: The firm lacked procedures for identifying, documenting, validating, reviewing, and approving pre-production design changes for Xpert Norovirus. Post-production design change verification procedures were also undefined. The firm's response was inadequate, lacking documentation of corrective action implementation, a retrospective review of design changes, employee training, and systemic corrective action for design control procedures. 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure did not require verification/validation to ensure no adverse effect on finished devices or dissemination of quality problem information to responsible personnel. The response was inadequate, lacking documentation of retrospective CAPA reviews for effectiveness, adverse effects, information dissemination, and completion, as well as evidence of training.