ANSM says Medreich plan will bring non-compliant Bollaram plant up to code
The French National Agency for the Safety of Medicines and Health Products made the comments in an update on the EudraGMP database this week, explaining that Medreich’s plan addresses issues raised during inspections of its facility in Bollaram.
ANSM inspectors first criticised operations at the facility - which is known as manufacturing unit V and makes beta-lactam antibiotic containing tablets and capsules - after a visit in 2013.
More problems were identified during a re-inspection a year later, including evidence of one case of data falsification, poor quality management and a lack of staff training protocols.
The results of the 2014 inspection prompted the issuance of a statement of non-compliance. Medreich says it has not supplied finished products to markets in the EU since the second ANSM visit.
Remediation plan
In this week’s update, the agency said “it received a comprehensive action plan that addresses the issues raised during the inspection. This action plan was reviewed and was found acceptable.”
However, ANSM does not intend to verify that Medreich’s plan is effective.
The agency said “due to the absence of any national product on the French market and the absence of any pending application involving this site, ANSM will not perform a follow-up inspection of this site to ensure the effective implementation of this action plan.”
It also advised that: “The statement of non-compliance previously issued is maintained and the site should not be named on any marketing authorisations whilst this statement remains in place.”
Medreich was acquired by Japan’s Meiji Seika Pharma in 2015.
The firm did not respond to a request for comment.
