Regulators in the E.U. have temporarily suspended a plant in Spain that makes an antibiotic after inspectors said it was too understaffed to safely manufacture its products.
According to a posting on the European Medicines Agency's website EudraGMDP, the Alcor plant in Guadalajara, Spain was inspected by Spanish authorities in June. They reported 29 deficiencies and classified 8 as major. It said the company proposed a corrective plan but, after evaluation, it was seen as doing too little and determined the facility is not meeting E.U. GMP standards. It temporarily suspended its marketing authorization.
Inspectors said the most serious lapse was the fact that workers had so much to do that it was creating a risk to quality. But there were other issues as well. They said the plant lacks a quality control laboratory that is suitable for performing chemical-physical testing and microbiological testing. There also were issues over poor documentation and inadequate management of raw materials.
The facility makes two products sold in Spain, an oral antibiotic and Jarabe Dr. Manceau syrup. The authorities said it was not believed that the products posed a risk and so did not ask for a recall.
Earlier this year, regulators in Spain found issues with a Barcelona facility owned by Farma Mediterrania. In that case, the inspector said the plant lacked an effective quality-assurance system, released batches without completing manufacturing protocols and used nonqualified equipment and procedures, among other violations. In addition to a recall, regulators said they intended to suspend all manufacturing and quality-control activities at the plant, prohibit the production of any new batches and inform consumers about the measures.
- access the report here
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