Following the inspection, the company provided a CAPA plan to the deficiencies [1 critical (The company did not have a correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management as evidenced by the findings related to the quality system), 9 major and 20 other findings] that was accepted. The company failed to follow-up on this plan and to meet the commitments made. The company changed its plans and no longer actively rectified the deficiencies to come in line with EU-GMP according to the mutually agreed reasonable time-frame. Action taken/proposed by the NCA: Prohibition of supply Sale, importation or distribution of products for medicinal use manufactured at this site, in part or in full, is prohibited.
Inspection Record
Zenabis Ltd — EU GMP NCR (EudraGMDP) Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
1Deviation, CAPA, and investigation
About this record
Extracted automatically from the document EMA (Europe) published on 2019-11-27. The source is available at the link above.
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.
Translation and classification are automated and may differ in nuance from the source.
