Inspectors find big issues at API repackager in France

Inspectors find big issues at API repackager in France

Sas Jarmat Laboratoire in Reventin Vaugris, France, has stopped its API repackaging operations and recalled all of its products after French inspectors discovered risks for cross-contamination at its facility.

According to a report posted by the European Medicines Agency, the company was primarily selling APIs to compounding pharmacies in the Europe.

French inspectors noted 21 deficiencies, including three they considered critical, including the possibilities of cross-contamination and the fact that the company was not testing products to see if they met specifications. In fact there were no batch records, they reported.

January 26, 2016 | By Eric Palmer

http://www.fiercepharmamanufacturing.com/

January 26, 2016 / Uncategorized