Madrid-based vaccine maker Angulema has been slapped by the Spanish Agency of Medicines and Medical Devices with noncompliance in its manufacturing processes and was ordered to recall more than 400 lots of its vaccines.
The action by Spain’s regulatory agency was posted on the European Medicines Agency (EMA) EudraGMDP site that was established to alert other European Commission countries that might also receive products from plants that have been cited.
During a November inspection of the Angulema facility, Spanish inspectors found critical and major deficiencies in the company’s quality system and manufacturing processes for products that included subcutaneous, sublingual and nasal formulations of bacterial vaccines, bacterial autovaccines, and allergenic vaccines.
The agency said the company did not have an effective pharmaceutical quality system and that Angulema released "batches of bacterial vaccines and bacterial auto-vaccines … without performing the sterility test according to [the European Pharmacopoeia] Eu. Ph.”
Additionally, inspectors found that a series of required process validation and media fill process simulations for aseptic processes were not conducted, and that the company didn’t perform validation activities for ensuring its bacterial vaccines and bacterial autovaccines were sterile and inactive.
Earlier this year, regulators in Spain found issues with the Alcor plant in Guadalajara, Spain, and a Barcelona facility owned by Farma Mediterrania. In the Farma Mediterrania case, inspectors found the facility lacked an effective quality-assurance system, released batches without completing manufacturing protocols and used nonqualified equipment and procedures, among other violations.