Algorithm s.a.l. — EU GMP NCR (EudraGMDP) Findings

Following the inspection, the team of the inspectors recorded 6 major deficiencies and 10 others all of which concerned failures in maintaining controlled environment such as pressure cascade, ineffective measures for cross-contamination such as improper handling of frequent power cuts, quality control issues, absence of toxicological evaluation of the multi production facility, inadequate presentation of the process validation, use of materials which may elevate the risk of contamination, warehouse issues such as limited space and lighting, improper gowning procedures and other document system failures. Since 2023 the company has managed to address some of the findings (major and other) however, failed to provide adequate rectifications within timeframe agreed on maintaining pressure cascade in liquid production line. Action taken/proposed by the NCA: Recall of batches already released No. Prohibition of supply Prohibition of supply from the date of issue and until this statement remains in place. No recall of any products will be enforced. Others The GMP certificates No. ALG01/20 & ALG01/2017 are suspended.