NORGINE LIMITED — MHRA GMP NCR Findings

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 the MA and GMP. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities. Action taken/proposed by the NCA: Action taken/proposed: suspension In part Withdrawal of current valid GMP certificates: UK MIA 322 INSP GMP 322/14798-0030[H] Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.