FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs

Inmunotek’s Manufacturing Authorization Pulled Due to GMP Deficiencies

April 15, 2016

Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies.

Following a March 15 and 16 inspection, the agency issued a non-compliance report that said the quality and sterility of the firm’s immunotherapy products could not be assured.

AEMPS further listed Inmunotek’s batch certification of immunological products, secondary packaging and quality control testing as being non-GMP compliant. The agency said the suspension will remain in effect until the firm implements appropriate corrective and preventive actions.