1Complaint and recall handling
Totally 25 deficiencies were found, 1 was classified as critical, 17 as major. Most of deficiencies was found on adjacent manufacturing site but some of them were common. 2 major deficiencies were found in the Quality Management - system of deviations and change control were not established. Other major deficiencies cover requirements on premises and equipment, e.g. storage rooms are not cleaned properly. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. sukls78312/2017 in Full Withdrawal, of current valid GMP certificate No. sukls426470/2018 GMP certificates invalidated Recall of batches already released A recall of medicinal products should be evaluated by involved NCAs following the assessment.
