Genovior Biotech Corporation — MHRA GMP NCR Findings

The inspection identified a critical finding regarding sterility assurance of product. The controls in place were such that there was a significant risk that product may not be sterile and that this would not be detected due to lack of robust and repeatable aseptic and sterilisation processes. A second critical finding was identified related to contamination and degradation controls. Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: N/a – none issued for EU GMP. Marketing authorisation action: The UK MAA has been withdrawn by the applicant. Recall of batches: No batches have been supplied to the UK or EU Prohibition of supply: No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.