We, Farmabios S.p.A., hereby notify

We, Farmabios S.p.A., hereby notify that during the last general GMP inspection performed by AIFA at ourmanufacturing site located in Via Pavia 1 27027 Gropello Cairoli PV Italy, on September 16th to 20th 2019,major observations were issued concerning the microbiological department.A risk was identified in relation with the deviations occurred and relevant to the sterile production, with apotential lack of control in the microbiological monitoring of the sterile manufacturing areas (that affects thequality system in place in the micro lab)A statement of non-compliance with GMP was issued relevant to the aseptically manufactured sterile APIsonly. We confirm that the registration for production of non-sterile APIs is maintained as the statement ofnon compliance does not impact the not sterile APIs manufactured at the site (non-sterile steroids/cytotoxicanticancer/high potent substances), as well the authorisation for APIs sterilized by gamma irradiation, as thestatement of non compliance does not impact the gamma irradiation that is performed by a contractmanufacturer. The sterility test results on the APIs manufactured were not highlighted as critical.Furthermore the sterility tests at release are performed by an external GMP qualified contractor.As immediate action based on outcome of the inspection, Farmabios precautionary decided to holdtemporarily, till the submission of CAPA plan, every manufacturing and release of new batches of sterilesteroids API.A CAPA plan, already discussed and agreed with the Authority, has been already submitted together with acomplete risk assessment relevant to the potential impact of the deviation occurred on the finished drugproducts. The estimated completion date for the CAPA plan activities is foreseen by December 2019.Farmabios will re-start manufacturing of sterile APIs in January 2020 and, after favourable conclusion of theGMP inspection by AIFA, the release of such substances.We are at disposal for any other information you may require.