Karoo Bioscience (Pty) Ltd. — EU GMP NCR (EudraGMDP) Findings

Following an on-site inspection at Karoo Bioscience (Pty) Ltd. in South Africa (4–7th April 2025) for non-sterile cannabis-based medicinal products, the draft post-inspection letter’s critical and major deficiencies were reviewed by the Inspectors' Review Group (IRG). The inspection aimed to evaluate the company's eligibility for EU GMP certification. Three critical and five major deficiencies were identified, including inadequate facility and equipment qualification, insufficient process validation, and limited GMP expertise within Quality Assurance. Major issues also involved poor risk assessments, weak documentation and data integrity controls, and deficiencies in line clearance, deviation management, and sampling practices. The company currently has no products on the EU/EEA market. Based on these findings, the IRG concluded that EU GMP certification could not be granted, and a statement of non-compliance with GMP will be issued as per the Compilation of Union Procedures. Action taken/proposed by the NCA: Others Member States should consider refraining from initiating or authorizing marketing authorization applications that list this site as a finished product manufacturing site until the recommended non-compliance statement is issued and remains in place.