ZHEJIANG MEDICINES COMPANY LTD — MHRA GMP NCR Findings

The inspection identified 2 critical findings; the first regarding sterility assurance and contamination controls, and the second regarding the validity and suitability of reported data. 1. The controls in place were such that they posed a significant risk of contaminating sterile medicinal products. 2. Reported data could not be relied upon and resulted in (but was not limited to) contaminated equipment being used with potential to contaminate the sterile products being manufactured. Action taken/proposed by the NCA: Reason: Not applicable – The site is not currently authorised to manufacture sterile medicinal products. The critical findings are attributed to the initial site inspection, based on an application made for the site to manufacture sterile medicinal products. The marketing authorisation applicant, post inspection, has withdrawn the application. Withdrawal of current valid GMP certificates: Not applicable – The site is not currently authorised to manufacture sterile medicinal products. The critical findings are attributed to the initial site inspection, based on an application made for the site to manufacture sterile medicinal products. The marketing authorisation applicant, post inspection, has withdrawn the application. Marketing authorisation action: Not applicable – The marketing authorisation applicant, post inspection, has withdrawn the application. Recall of batches: Not applicable – no batches have been released. Site is not authorised to manufacture sterile medicinal products.