Cubit Lifesciences Limited Liability Partnership — EU GMP NCR (EudraGMDP) Findings

A follow-up GMP inspection was conducted at the aforementioned site by the MMA, as an EU Competent Authority, executed during the period of 27th January 2024 – 1st February 2024. The inspection focus, as a follow up inspection, was aligned with the recommendations stemming from a previous GMP inspection conducted between 18th – 23rd February 2023. The previous inspection had resulted in the identification of 2 critical, 3 major and a total of 17 other observed issues. The principal objective of the follow-up inspection was to assess and validate the effective incorporation, spanning the entirety of the facility and the pharmaceutical quality system, of the documented Corrective and Preventive Actions (CAPAs) and commitments presented by Cubit Lifesciences in response to the February 2023 inspection. During the follow-up inspection, the inspectors found two critical, four major and twelve other findings, some of which were already identified in the initial February 2023 inspection and still were found not fully addressed and implemented in the follow-up inspection, indicating an improper implementation of all CAPAs throughout the whole facility. As a result of this outcome, the Inspection Review Group (IRG) at the Malta Medicines Authority has met and decided that a Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC is to be issued for the site. Action taken/proposed by the NCA: Others The manufacturer did not previously have EU GMP certification. An EU GMP certificate will not be issued.