UK MHRA Findings

An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of GMP. Action taken/proposed by the NCA: Action taken/proposed: suspension in full Withdrawal of current valid GMP certificates: UK MIA(IMP) 322 INSP IMP 322/14798-0031[I]

An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of the MA and GMP. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities. Action taken/proposed by the NCA: Action taken/proposed: suspension In part Withdrawal of current valid GMP certificates: UK MIA 322 INSP GMP 322/14798-0030[H] Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.

An unannounced inspection of the facility was conducted from 15 to 23 June 2026. This inspection was triggered following three Class II recalls of medicinal products supplied to the UK market. Five critical deficiencies were identified, including: - Senior Management had failed to ensure that there was a comprehensively designed and correctly implemented Pharmaceutical Quality System - Lack of adequate and effective procedures and controls to prevent mix-ups and substitution of materials - Failure to ensure that risks of contamination and cross-contamination were assessed and minimised - Deficiencies in the management and investigation of serious quality defects - Generation and retention of unreliable GMP records, compromising data integrity and assurance of product quality Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: The site does not hold a manufacturing authorisation because it is located in a 3rd country. The MHRA has not issued a GMP certificate for this site. EU Competent Authorities should consider a withdrawal of the current EU GMP certificate. Prohibition of supply: No further batches to be supplied to the UK market until an inspection confirms adequate corrective and preventative actions have been taken.

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.

Following inspections on 25 July 2023 and 8 April 2024, critical deficiencies were identified in relation to data integrity, good distribution practice, lack of protection from microbial and other contamination, and inadequate control of packaging changes. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities. Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: UK MIA 17907 INSP GMP 17907/13988-0035[H] Recall of batches: No recalls necessary at the time of issuance of this SONC. Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.

The inspection identified a critical finding regarding sterility assurance of product. The controls in place were such that there was a significant risk that product may not be sterile and that this would not be detected due to lack of robust and repeatable aseptic and sterilisation processes. A second critical finding was identified related to contamination and degradation controls. Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: N/a – none issued for EU GMP. Marketing authorisation action: The UK MAA has been withdrawn by the applicant. Recall of batches: No batches have been supplied to the UK or EU Prohibition of supply: No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.