VAKOS XT a.s. — EU GMP NCR (EudraGMDP) Findings

Totally 25 deficiencies were found, 1 was classified as critical, 17 as major. The critical deficiency was related to premises: A mould was found on several places in the washing room. 2 major deficiencies were found in the Quality Management - system of deviations and change control was not established. 16 major deficiencies cover requirements on premises and equipment, e.g. production a storage rooms are not cleaned properly, dead insects were found in light covers in production rooms, walls and ceilings do not allow a proper cleaning. HVAC system is not set properly, a pressure drop leads from the room with the highest risk of contamination to production rooms. Microbiological monitoring is insufficient. Computerized systems in QC are not controlled. Cleaning validation was performed only formally. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. sukls78312/2017 in Full This manufacturer should not be authorized in any new/ongoing marketing authorization or variation application. Withdrawal, of current valid GMP certificate No. sukls426470/2018 GMP certificates invalidated Suspension of the marketing authorisation(s) This manufacturer should not be authorized in any new/ongoing marketing authorization or variation application. Recall of batches already released A recall of medicinal products should be evaluated by involved NCAs following the assessment.