Przedsiebiorstwo Farmaceutyczne Okoniewscy Vetos Farma Sp. z o.o. — EU GMP NCR (EudraGMDP) Findings

An unannounced inspection was carried out in connection with the suspicion of conducting activities in the scope not covered by the registration in the National Register of Manufacturers, Importers and Distributors of Active Substances. The main assumptions during this inspection were to check the distribution chains of the active substance streptomycin sulphate and to verify the activities covered by the MIA. During the inspection 2 critical, 3 major and 1 finding classified as other were identified. The critical deficiencies concerned: - unauthorised sale of the active substance: Streptomycin sulphate, previously purchased for veterinary manufacture product Strepto 37.5; powder for solution for pigs. - unauthorised sale of 17 barrels of the active substance: Streptomycin sulphate s: L6A-220413-5 to retail customers, of which 5 were previously released for the manufacture of the medicinal product Strepto 37.5; powder for solution for pigs. - Sales of APIs as chemical substances to retail customers. - Lack of consistency and reliability of the entry in the “Batch Processing Records” for the calculation of the quantities of starting materials (including active substance) used in the manufacture of a batch of the veterinary medicinal product Strepto 37.5; powder for solution for pigs. There is no clearly defined link between the record and the production operation. - storage of APIs for sale under uncontrolled conditions, in a room not included in the Site Master File. - performing of inter-warehouse operations between the plant's warehouse and the chemical substances warehouse and waste warehouse that were not included in the SMF. The evidence gathered during the inspection shows that Vetos-Farma as the MIA holder purchases from APIs importers streptomycin sulphate, which should be used in the manufacture of the veterinary medicinal product Strepto 37.5; powder for solution for pigs. However, part of the purchased active substance is subject to further distribution to unknown customers by the Vetos-Farma without being authorised, i.e. not being entered in the National Register of Manufacturers, Importers and Distributors of Active Substances as distributors of active substances. Additionally, the manufacturer does not keep sales records enabling customers identification. Action taken/proposed by the NCA: Revocation of the marketing authorisation(s) Revocation of Manufacturing Authorisation No. 011/0233/15 of 4.10.2022 decision under case number NPA.402.2.2024.KWO.4 Revocation of Registration in the National Register of Manufacturers, Importers and Distributors of Active Substances No. 150/WTC0233/API/18 of 23.2.2023 – decision under case number NPA.401.1.2024.KWO.3