EMA says Spain has taken action against drugmaker for shortcomings

Print 20 January 2016
Eric Palmer / FeircePharmaManufacturing

Spanish regulators have yanked the manufacturing authorization of a drugmaker there after an inspection left them unimpressed with the drugmaker's controls for keeping products sterile.

The action was taken against Desarrollos Farmacéuticos Bajo Aragón, a drugmaker in Alcorisa. Regulators were not specific but said that the company, which manufactures capsules, tablets and liquids, did not have in place "a quality management system that could ensure accuracy and completeness of the critical records data."

European inspectors have been busy of late. French regulators recently took action against a Shaoxing Pharmaceutical plant in Zhejiang province after inspectors noted more than a dozen deficiencies. Of most concern was the fact that the company allegedly falsified the source of its API, thiamphenicol, and released product without traceability of testing measures.

And regulators in Sweden had problems with an AstraZeneca ($AZN) plant in India that they said had released in Sweden and China an API for asthma drugs even though the batches had failed some validation testing. AstraZeneca has stopped production and has said it will close the plant in Bangalore. The company said that all of the products manufactured there "and released for formulation in 2014 met registered specifications."

The European Medicines Agency (EMA) posts the actions to its EudraGMDP site to alert other European Commission countries that might also receive products from plants that have been cited.

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