Iason Italia, a Rome-based radiopharmaceutical manufacturer, has been slapped with a noncompliance report by the Italian Medicines Agency (AIFA) following an October inspection of its facility that found 19 deficiencies in the operation.
The agency issued a noncompliance report Wednesday that said Iason didn't comply with good manufacturing practice requirements. During an Oct. 8 inspection, the agency identified 19 deficiencies of which three were rated as critical and 11 as major, the Regulatory Affairs Professionals Society reported on its website.
The noncompliance report was the third such report to be posted by the EudraGMDP--the European database of pharmaceutical manufacturing violations--in recent months. The other noncompliance reports were related to Cargill's plant in Lannilis, France, that turns seaweed into alginate, and a GlaxoSmithKline ($GSK) facility in Tianjin, China.
"The main deficiencies were related to the Quality Management and the Quality Assurance Systems also in terms of sterility assurance and risk of contamination/defect of the final product," AIFA said in its report.
A critical issue the inspection found at the Iason facility was a failure to fully investigate and document out-of-specification results for microbiological environmental monitoring for radiopharmaceuticals intended to be aseptically prepared, the agency said.
- check out the RAPS posting