Fagofarma s.r.o. — EU GMP NCR (EudraGMDP) Findings

The inspection team identified a total 19 deficiencies: two classified as critical, 13 as major and 4 as minor. The critical deficiencies concerned in the implementation of the pharmaceutical quality system and in the knowledge, experience and number of qualified personnel. The principal deficiencies across most areas of GMP involved missing or inadequate records of deviation investigation, change management, training, validation and qualification, documentation management, risk assessment and stability studies. Critical deficiencies: 1: The pharmaceutical quality system, including good manufacturing practice, is not functional. The system has not been implemented and properly documented, and the monitoring of its effectiveness is not based on real data and quality risk management. Records were either missing or incorrect. 2: The company employs six staff workers. Since the last inspection, three personal changes have occurred in the area of plant management and quality assurance. New employees, in some areas, do not have sufficient knowledge and experience to perform and supervise the relevant activities. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. sukls218593/2023 NCR Prohibition of supply prohibition of supply is recommended