1Documentation and records
The company held a restricted manufacturing authorisation until 30 June 2020. Based on the evaluation of the company's CAPA plan the manufacturing authorisation cannot be prolonged. Major systemic deficiencies in the areas of supplier qualification, change management, deviation management, qualification of equipment, validation of computerised systems and good documentation practice could not be resolved. Action taken/proposed by the NCA: Revocation of the manufacturing authorisation No. 482723 in Full Withdrawal, of current valid GMP certificate No. 482723-0003 The company held a restricted GMP certificate valid until 30 June 2020. A new certificate will not be issued.
