Marfleet Analytical Services Limited — MHRA GMP NCR Findings

The company failed to operate a compliant GMP quality management system. This was identified during inspection Insp GMP/IMP 46334/14567004-0005. Over two subsequent inspections the company could not demonstrate that all CAPA actions committed to in response to the initial inspection had been implemented, and that the CAPA which had been implemented were effective. Action taken/proposed by the NCA: Action taken/proposed: revocation Withdrawal of current valid GMP certificates: UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [H] and UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [V] Marketing authorisation value: Requested variation Marketing authorisation action: Marketing authorisation holders should remove the laboratory from applicable authorisations by variation.