Italy manufacturing-site findings

An inspection performed by AIFA between 22 and 24 June 2026 identified serious and systemic deficiencies affecting the Pharmaceutical Quality System and the implementation of EU GMP requirements applicable to aseptic preparation of parenteral nutrition products. Twelve major deficiencies were identified. • Pharmaceutical Quality System deficiencies. • Inadequate documentation and data integrity controls. • Deficiencies in computerized systems validation and electronic data management. • Inadequate Contamination Control Strategy. • Deficiencies in aseptic process simulation (APS/media fill). • Deficiencies in environmental and microbiological monitoring. • Inadequate qualification and validation activities. • Deficiencies in personnel training, supplier qualification and quality control oversight. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. IT/265/H/2024 Regulatory Action Taken A Statement of Non-Compliance with GMP has been issued. Suspension of the manufacturing authorization No. aM-194/2024. While a state of non-compliance with GMP requirements was identified, the Inspection Team also took into account the nature of the medicinal products manufactured at the site, which are intended for patients receiving parenteral nutrition and therefore constitute essential and potentially life-sustaining therapies. Based on the inspection findings, no evidence emerged indicating an immediate and concrete risk to patient health associated with batches already manufactured and distributed. Consequently, following a risk-benefit assessment, which was considered favourable to the continued use of the medicinal products already supplied, the Inspection Team does not consider it necessary, based on the information currently available, to recommend the recall of batches already manufactured and distributed. Others The site manufactures sterile parenteral nutrition preparations exclusively on a medical prescription basis pursuant to Article 5 of Directive 2001/83/EC, as transposed into Italian legislation by Legislative Decree No. 219/2006. Parenteral nutrition preparations are supplied exclusively to the Italian market on a medical prescription basis (Article 5 of Directive 2001/83/EC). No actions for other countries are needed.

Your program for the visual inspection ofsterih drug products does not provide adequate assurance that finished products manufactured at your facility possess their purported quality attributes, including that they are essentially free from particulate matter.

Quality Unit (QU) oversight over the manufacturing process is inadequate.

Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not fully established or followed.

Your rogram for the environmental control of classified areas, including critical supporting area for the Grade A Cb><-O does not provide assurance ofyour ability to adequately clean and/or disinfect your classified areas and detect levels oftheir microbial contamination.

Failure to establish process controls and testing designed to assure that the drug products you manufacture have the identity, strength, quality and purity that it purports or is represented to possess.