Regulator suspends Spanish drugmaker over 'critical quality defects'

Regulators in Spain are punishing a Barcelona-based drugmaker for a series of manufacturing shortfalls, recalling all batches produced by the company, Farma Mediterrania, from 2014 to present. The crackdown is the second in as many months by Spanish authorities on local producers.

According to a posting on the European Medicines Agency's website EudraGMDP, an inspection of a Barcelona facility owned by Farma Mediterrania last month turned up 8 critical deficiencies and 9 major deficiencies. As a result, in addition to the recall, regulators said they intend to suspend all manufacturing and quality-control activities at the plant, prohibit the production of any new batches and inform consumers about the measures.

The deficiencies, numerous in quantity, impacted the plant's packaging operations and quality-control testing as well as its lyophilisates and small-volume liquid products. According to the regulator, the drugmaker lacked an effective quality-assurance system, released batches without completing manufacturing protocols and used nonqualified equipment and procedures, among other violations. The notice said a "high number of critical quality defects," such as visible particles, were present, but the drugmaker didn't investigate the deviations.

Farma Mediterrania is a lab specializing in small-volume sterile injectables and ophthalmics, according to its website, and "is constantly evolving to always offer the maximum guarantee of quality," according to a translation. "Our finished products go through strict quality control process in each of its processes," the site reads.

The regulatory rebuke is just the newest example of European officials holding local and international drugmakers accountable since the start of the new year. Last month, Spanish authorities pulled the manufacturing authorization for Desarrollos Farmacéuticos Bajo Aragón in Alcorisa because the company lacked a quality-assurance system. Also in January, France's drug regulator flagged a plant in China for 18 deficiencies and issued a noncompliance notice.

The action in Europe also comes as compounding laboratories in the U.S. have come under close scrutiny by the FDA. The agency has been inspecting the labs throughout the country, requiring many to recall all of their products if conditions are suspect, and even launching legal actions against some that have been reluctant to comply with FDA mandates. 

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