Remediation activities at non-GMP compliant site ‘progressing well’, says Recipharm
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) routinely inspected the Swedish contract development and manufacturing organisation (CDMO)’s facility on August 24, 2018.
According to the agency, inspectors observed that the facility’s potent drug production area lacked appropriate measures to prevent and detect cross-contamination.
The MHRA considered the lack of such measures “presented a risk that cross-contamination between products could occur and would not be detected”.
According to Recipharm, the agency has since made a formal decision regarding on-site production for certain drug products: “On 24th September 2018, the MHRA formally restricted the manufacturing licence for a limited number of products,” a company spokesperson told us.
“We continue to work with the authorities and customers to implement appropriate remediation activities which is progressing well,” the spokesperson added.
Recipharm appeared in headlines earlier this week, having reversed its decision to close a sachet and stick pack-filling facility in Höganäs, Sweden.
“The decision to stay in Höganäs is a consequence of the increased demand for the technology and capacity we can offer,” wrote CEO Thomas Eldered in a statement.
“This has been somewhat unexpected, but we are of course pleased to see new customers entering in Höganäs and that, by this, we are also able to continue the services to existing customers,” he added.
