The Spanish Agency of Medicines and Medical Devices (AEMPS) ordered the recall and suspended the San Sebastian de los Reyes site’s manufacturing license after identifying a number of problems.
“The deficiencies detected on the last inspection carried out on 15-16/03/2016 impact on the Quality system of the site and the manufacturing process of sterile immunological products.”
“The quality, and especially the sterility of the products manufactured cannot be assured. As a consequence of this and to prevent risk for the patients, AEMPS has decided to suspend the site´s manufacturer authorization for finished products until the implementation of necessary corrective/preventive actions.”
Operations at Immunotek’s other manufacturing facility in Alcala de Henares – also in Madrid – are unaffected. Details of the recalled vaccines were not disclosed.
Inmunotek describes itself as a supplier of anti-allergy and immunology products.
Response
Miguel Casanovas, Inmunotek medical director, told us “the Spanish Authorities temporally suspended the manufacturing authorization of our facilities in San Sebastián de los Reyes based on documentary inspection.”
He added the site was closed for maintenance at the time of the AEMPS inspection and stressed that “this alert is due to a documental inspection and not, in any case, due to the analysis of the product by the authorities or to an adverse reaction of infectious complications after the administration of these allergen vaccines.”
AEMPS did not respond to a request for more information.