1Contamination control
The inspection in October 2019 identified further chronic non-compliance with EU GMP and failure to adequately address deficiencies from previous inspections. In process checks were not performed effectively and an adequate risk based approach to cross contamination control was not demonstrated. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. UK GMP 31201 Insp GMP 31201/349094-0008 Withdrawal of previous GMP Certificate No: UK GMP 31201 Insp GMP 31201/349094-0008 Issue of a statement of non-compliance. Prohibition of supply Only batches of critical products to be supplied to EU markets while this statement of non-compliance remains in force.
