Firm Record

Fagofarma s.r.o. findings history

2 findings from 2 inspection documents published by regulators. Each row below says what its date means.

EMA (Europe) 2025-12-16 ~ 2025-12-16 2 documents 2 findings

Areas cited

Deviation, CAPA, and investigation

Published inspection documents

2025-12-16 EMA (Europe) 1 findingsDeviation, CAPA, and investigation The inspection team identified a total of 25 deficiencies: three classified as critical, 17 as major and 5 as minor. Two critical deficiencies concerned the implementation of the pharmaceutical quality system and the knowledge, experience, and number of qualified personnel. The third critical deficiency related to the certification of manufactured preparations and the maintenance of a register of manufactured and certified batches. The principal deficiencies across most areas of GMP involved missing or inadequate records of deviation investigations, 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. 3: The register of manufactured batches is maintained only in an Excel spreadsheet. The inspected entity failed to provide evidence of certification of several batches by a Qualified Person. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. sukls218594/2023 NCR Suspension of clinical trials Suspension of clinical trials (if any) is recommended 2025-12-16 EMA (Europe) 1 findingsDeviation, CAPA, and investigation 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

About this page

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Fagofarma s.r.o. — including inspection classifications Browse by document Go to Findings search