1Validation and qualification
An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of GMP. Action taken/proposed by the NCA: Action taken/proposed: suspension in full Withdrawal of current valid GMP certificates: UK MIA(IMP) 322 INSP IMP 322/14798-0031[I]
