Geno Pharmaceuticals Private Limited — MHRA GMP NCR Findings

An unannounced inspection of the facility was conducted from 15 to 23 June 2026. This inspection was triggered following three Class II recalls of medicinal products supplied to the UK market. Five critical deficiencies were identified, including: - Senior Management had failed to ensure that there was a comprehensively designed and correctly implemented Pharmaceutical Quality System - Lack of adequate and effective procedures and controls to prevent mix-ups and substitution of materials - Failure to ensure that risks of contamination and cross-contamination were assessed and minimised - Deficiencies in the management and investigation of serious quality defects - Generation and retention of unreliable GMP records, compromising data integrity and assurance of product quality Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: The site does not hold a manufacturing authorisation because it is located in a 3rd country. The MHRA has not issued a GMP certificate for this site. EU Competent Authorities should consider a withdrawal of the current EU GMP certificate. Prohibition of supply: No further batches to be supplied to the UK market until an inspection confirms adequate corrective and preventative actions have been taken.